Depuy Synthes Maxillofacial Portfolio - MR Conditional

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 30, 2019 Synthes (USA) Products LLC Satapa Dhamankar Regulatory Affairs Specialist II 1301 Goshen Parkway West Chester, Pennsylvania 19380 Re: K192655 Trade/Device Name: DePuy Synthes Maxillofacial Portfolio - MR Conditional Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: December 23, 2019 Received: December 26, 2019 Dear Satapa Dhamankar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes MatrixWAVE MMF System (originally cleared per K141165) The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. | Type of Use (Select one or both, as applicable) | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {3}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K121574) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: - Trauma · Reconstructive surgery · Orthognathic surgery (surgical correction of dentofacial deformities) Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {4}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K113567) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: - Trauma · Reconstructive surgery · Orthognathic surgery (surgical correction of dentofacial deformities) Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {5}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes Dentoalveolar Bone Fixation System (originally cleared per K102656) The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {6}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Subcondylar Plates (originally cleared per K091233) The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {7}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates (originally cleared per K091144) The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {8}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio – MR Conditional Indications for Use (Describe) DePuy Synthes MatrixORTHOGNATHIC Plating System (originally cleared per K083388) The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with Synthes Matrix screws. System components are manufactured in either titanium alloy and are intended for single use only. The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: · Fractures of the midface and maxillofacial skeleton - · LeFort I osteotomies, sagittal split osteotomies and genioplasties - · Orthognathic surgery including reconstructive procedures | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {9}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K082335) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {10}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K080331) The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton, maxillofacial surgery, reconstructive procedures and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {11}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes MatrixMANDIBLE Plate and Screw System (originally cleared per K063790) The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). | Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {12}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Craniofacial Plate and Screw System (originally cleared per K050608) The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {13}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Neuro Plate and Screw System (originally cleared per K042365) The DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {14}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates (originally cleared per K033121) The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {15}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Orbital Plates (originally cleared per K031761) The DePuy Synthes Orbital Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------| | <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {16}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Low Profile Neuro System (originally cleared per K022012) The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midfacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Type of Use (Select one or both, as applicable) | <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2H2.66667C2.29848 2 2 1.70152 2 1.33333V2C2 2.36819 2.29848 2.66667 2.66667 2.66667H13.3333C13.6985 2.66667 14 2.36819 14 2V1.33333C14 1.70152 13.6985 2 13.3333 2Z" fill="black"></path> <path d="M13.3333 14H2.66667C2.29848 14 2 13.6318 2 13.2637V14C2 13.6318 2.29848 13.3333 2.66667 13.3333H13.3333C13.6985 13.3333 14 13.6318 14 14V13.2637C14 13.6318 13.6985 14 13.3333 14Z" fill="black"></path> <path d="M13.3333 8H2.66667C2.29848 8 2 7.63181 2 7.26368V8C2 7.63181 2.29848 7.33333 2.66667 7.33333H13.3333C13.6985 7.33333 14 7.63181 14 8V7.26368C14 7.63181 13.6985 8 13.3333 8Z" fill="black"></path> <path d="M5.33333 11.3333L5.33333 4.66667" stroke="black" stroke-linecap="round" stroke-width="1.33333"></path> <path d="M10.6667 11.3333L10.6667 4.66667" stroke="black" stroke-linecap="round" stroke-width="1.33333"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="12" stroke="black" stroke-width="1.5" width="12" x="2" y="2"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {17}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K022005) The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <b> <div style="display:inline-block; width:15px; height:15px; border: 1px solid black;"> <div style="text-align: center;">X</div> </div> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | <div> <span> <b> <div style="display:inline-block; width:15px; height:15px; border: 1px solid black;"> </div> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {18}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional # Indications for Use (Describe) DePuy Synthes Translating Maxillary Distractor (Originally cleared per K020505) The DePuy Synthes Translating Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 807 Subpart C) | |----------------------------------------------|---------------------------------------------| |----------------------------------------------|---------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) |__ Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {19}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Midface Distractor (Originally cleared per K010499) The DePuy Synthes Midface Distractor is intended for use in adult and pediatic populations for the treatment of midface conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of the midfacial bones. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|--| | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {20}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Maxillary Distractor (Originally cleared per K003393) The DePuy Synthes Maxillary Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically it is intended for distraction of the maxilla utilizing a LeFort I osteotomy in adult and pediatric populations. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {21}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Orbital Mesh Plates (Originally cleared per K001311) The DePuy Synthes Orbital Mesh Plates for the Midfacial System are indicated for selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {22}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes 2.0 mm Locking Plate System (2.0 LPS) (originally cleared per K974555) The DePuy Synthes 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). Type of Use (Select one or both, as applicable) | <span style="padding-right: 5px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995.# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov {23}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes 2.4 mm Universal Locking Plate System (originally cleared per K961421) The DePuy Synthes 2.4 mm Universal Locking Plate and screw system, that is intended for mandible trauma and reconstruction procedures. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |---------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {24}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Mandibular Modular Fixation System (originally cleared per K954385) The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in: · Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {25}------------------------------------------------ 510(k) Number (if known) K192655 Device Name DePuy Synthes Maxillofacial Portfolio - MR Conditional Indications for Use (Describe) DePuy Synthes Maxillofacial Titanium Micro Set (originally cleared per K912932) General indications: - Maxillofacial surgery Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov {26}------------------------------------------------ ## 510(k) Summary 1. Date Prepared: December 23, 2019 #### Submitter 1.1. # Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com # Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixWAVE MMF System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY #### 1.3. Predicate Device K141165 MatrixWAVE MMF System #### Device Description 1.4. The DePuy Synthes MatrixWAVE MMF is a bone-borne maxillomandibular fixation (MMF) system that consists of wave shaped plates (made from commercially pure Titanium) that are attached to the dental arches with self-drilling locking screws (made from Titanium alloy, Ti-6Al-7Nb). The system is intended for temporary stabilization of mandibular and maxillary fractures and osteotomies to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (approximately 6-8 weeks). The dental arches are brought into occlusion by wiring around the plate hooks and/or accessible screw heads. {27}------------------------------------------------ The DePuy Synthes MatrixWAVE MMF System is indicated for the temporary treatment of mandibular and maxillary fractures and osteotomies in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted. ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixWAVE MMF System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system. | K192655 | K141165 | |-----------------------------------------------|-----------------------------------------------| | For the temporary treatment of mandibular | For the temporary treatment of mandibular | | and maxillary fractures and osteotomies in | and maxillary fractures and osteotomies in | | adults and adolescents (age 12 and higher) in | adults and adolescents (age 12 and higher) in | | whom permanent teeth have erupted. | whom permanent teeth have erupted. | ## Performance Testing 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixWAVE MMF System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## Conclusion 1.8. {28}------------------------------------------------ Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 # Product Code(s): JEY - 1.3. Predicate Device K121574 MatrixMANDIBLE Plate and Screw System #### Device Description 1.4. The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. System implants are manufactured in either titanium or titanium alloy and are intended for single use only. The DePuy Synthes MatrixMANDIBLE screws that are the subject of this premarket notification are made from titanium alloy (Ti-6A1-7Nb) and are available in a diameter of 2.0 mm and lengths ranging from 4 mm to 8 mm, and have a thread pitch of 0.5 mm. These screws work with all plates within the DePuy Synthes MatrixMANDIBLE Plate and Screw System. {29}------------------------------------------------ These devices are offered, non-sterile and must be sterilized prior to use. DePuy Synthes MatrixMANDLBLE screws are intended for single use. ## 1.5. Indications for Use The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: - Trauma - · Reconstructive surgery - Orthognathic surgery (surgical correction of dentofacial deformities) ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system. | K192655 | K121574 | |---------------------------------------------|------------------------------------------------| | For oral, maxillofacial surgery: | For oral, maxillofacial surgery: | | • Trauma | • Trauma | | • Reconstructive surgery | • Reconstructive surgery | | • Orthognathic surgery (surgical correction | • Orthognathic surgery (surgical correction of | | of dentofacial deformities) | dentofacial deformities) | ## 1.7. Performance Testing Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Plate and Screw System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## 1.8. Conclusion {30}------------------------------------------------ Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY - 1.3. Predicate Device K113567 MatrixMANDIBLE Plate and Screw System #### Device Description 1.4. The DePuy Synthes MatrixMANDIBLE Plate and Screw System consists of a variety of plates offered in multiple shapes and a variety of screws offered in multiple diameters and lengths to meet the anatomical needs of the patient. This submission pertains to 1.5 mm thick MatrixMANDIBLE Reconstruction Plates, which are available as left and right single angle reconstruction plates and in three sizes of double angle reconstruction plates. These plates are made from pure titanium and may be offered sterile or non-sterile (non-sterile implants must be sterilized prior to use). {31}------------------------------------------------ DePuy Synthes MatrixMANDIBLE 1.5 mm thick reconstruction plates are intended for single use only. ## 1.5. Indications for Use The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery: - Trauma - · Reconstructive surgery - Orthognathic surgery (surgical correction of dentofacial deformities) ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system. | K192655 | K113567 | |---------------------------------------------|------------------------------------------------| | For oral, maxillofacial surgery: | For oral, maxillofacial surgery: | | • Trauma | • Trauma | | • Reconstructive surgery | • Reconstructive surgery | | • Orthognathic surgery (surgical correction | • Orthognathic surgery (surgical correction of | | of dentofacial deformities) | dentofacial deformities) | ## 1.7. Performance Testing Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Plate and Screw System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## 1.8. Conclusion {32}------------------------------------------------ Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes Dentoalveolar Bone Fixation System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY #### 1.3. Predicate Device K102656 Synthes Dentoalveolar Bone Fixation System #### Device Description 1.4. The DePuy Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw system intended to be implanted intraorally for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. # Screws The System includes 1.3 mm, 1.5 mm, and 2.0 mm diameter cortex screws in lengths from 3 mm to 20 mm. Screws are offered with both self-tapping and self drilling tips. Screws are manufactured from titanium alloy (Ti-6A1-7Nb). {33}------------------------------------------------ # Plates and Meshes The System includes plates and meshes that come in a variety of configurations to accommodate various dentoalveolar defect sites. The plates attach to bone via titanium cortex screws. Plates and meshes are manufactured from commercially pure titanium. ## 1.5. Indications for Use The DePuy Synthes Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge. #### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes Dentoalveolar Bone Fixation System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system. | K192655 | K102656 | |----------------------------------------------|----------------------------------------------| | For use in non-load bearing applications for | For use in non-load bearing applications for | | maintaining the relative position of and/or | maintaining the relative position of and/or | | containing bony fragments, bone grafts | containing bony fragments, bone grafts | | (autograft or allograft), or bone graft | (autograft or allograft), or bone graft | | substitutes in reconstruction of maxillary | substitutes in reconstruction of maxillary | | and/or mandibular areas, including the | and/or mandibular areas, including the | | dentoalveolar ridge. | dentoalveolar ridge. | ## Performance Testing 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes Dentoalveolar Bone Fixation System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## 1.8. Conclusion {34}------------------------------------------------ Date Prepared: December 23, 2019 #### Submitter 1.1. Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixMANDIBLE Subcondylar Plates Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY - 1.3. Predicate Device K091233 Synthes MatrixMANDIBLE Subcondylar Plates #### Device Description 1.4. The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are designed specifically to match the anatomy of the subcondylar region of the mandible. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only. {35}------------------------------------------------ The DePuy Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible. ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Subcondylar Plates. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system. | K192655 | K091233 | |---------------------------------------------|----------------------------------------------| | For oral, maxillofacial surgery; trauma and | For oral, maxillofacial surgery; trauma and | | reconstructive surgery, specifically for | reconstructive surgery, specifically for | | fractures of the subcondylar region of the | fractures of the subcondylar region of the | | mandible and fractures of the condylar | mandible and fractures of the condylar basis | | basis region of the mandible. | region of the mandible. | ## Performance Testing 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Subcondylar Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## 1.8. Conclusion {36}------------------------------------------------ Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY #### 1.3. Predicate Device K091144 Synthes MatrixMANDIBLE Performed Reconstruction Plates #### Device Description 1.4. The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with DePuy Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium alloy and are intended for single use only. #### Indications for Use 1.5. The DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary {37}------------------------------------------------ mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures. ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding "- MR Conditional" to the name of each subject system. | K192655 | K091144 | |---------------------------------------------|---------------------------------------------| | For use in oral and maxillofacial surgery, | For use in oral and maxillofacial surgery, | | trauma and reconstructive surgery. This | trauma and reconstructive surgery. This | | includes primary mandibular reconstruction, | includes primary mandibular reconstruction, | | comminuted fractures and temporary | comminuted fractures and temporary | | bridging pending delayed secondary | bridging pending delayed<br>secondary | | reconstruction, including fractures of | reconstruction, including fractures of | | edentulous and/or atrophic mandibles, as | edentulous and/or atrophic mandibles, as | | well as unstable fractures. | well as unstable fractures. | ## Performance Testing 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixMANDIBLE Preformed Reconstruction Plates in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. ## Conclusion 1.8. {38}------------------------------------------------ Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixORTHOGNATHIC Plating System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 # Product Code(s): JEY #### 1.3. Predicate Device # K083388 Synthes MatrixORTHOGNATHIC Plating System #### Device Description 1.4. The DePuy Synthes MatrixORTHOGNATHIC Plating System consists of a variety of plates that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with DePuy Synthes Matrix screws. System components are manufactured in either titanium or titanium alloy and are intended for single use only. #### Indications for Use 1.5. The DePuy Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and {39}------------------------------------------------ selective orthognathic surgery of the maxilla, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific Indications for Use: - . Fractures of the midface and maxillofacial skeleton - . LeFort I osteotomies, sagittal split osteotomies and genioplasties - Orthognathic surgery including reconstructive procedures ● ## 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixORTHOGNATHIC Plating System. The intended use and technological characteristics of the devices remains unchanged. The device name has been updated to reflect the current company name, DePuy Synthes, and indicate MR Conditional use by adding " - MR Conditional" to the name of each subject system. | K192655 | K083388 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | For use in selective trauma of the midface<br>and maxillofacial skeleton; maxillofacial<br>surgery; reconstructive procedures; and<br>selective orthognathic surgery of the maxilla,<br>mandible and chin in adolescents (greater<br>than 12 to 21 years of age) and adults. | For use in selective trauma of the midface and<br>craniofacial skeleton; craniofacial surgery;<br>reconstructive procedures; and selective<br>orthognathic surgery of the maxilla, mandible<br>and chin in adolescents (greater than 12 to 21<br>years of age) and adults. | | Specific Indications for Use: | Specific Indications for Use: | | • Fractures of the midface and<br>maxillofacial skeleton | • Fractures of the midface and<br>craniofacial skeleton | | • LeFort I osteotomies, sagittal split<br>osteotomies and genioplasties | • LeFort I osteotomies, sagittal split<br>osteotomies and genioplasties | | • Orthognathic surgery including<br>reconstructive procedures | • Orthognathic surgery including<br>reconstructive procedures | ## Performance Testing 1.7. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes MatrixORTHOGNATHIC Plating System in the MR environment including assessment of magnetically induced displacement force (ASTM F2052-14) and torque (ASTM F2213-06), radio frequency (RF) heating (ASTM F2182-11a), and image artifacts (ASTM F2119-07). The DUKE model places devices in the clinically relevant anatomic position. The DUKE results will be used for labeling of RF heating. {40}------------------------------------------------ # 1.8. Conclusion {41}------------------------------------------------ # 510(k) Summary 1. Date Prepared: December 23, 2019 #### 1.1. Submitter Primary Contact: Satapa Dhamankar Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: 610-719-6574 Email: sdhamank@its.jnj.com Alternate Contact: Jeffrey Krawiec, PhD Senior Regulatory Affairs Specialist DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5356 Email: jkrawiec@its.jnj.com #### 1.2. Device Trade Name: DePuy Synthes Maxillofacial Portfolio – MR Conditional Name of Device: DePuy Synthes MatrixMANDIBLE Plate and Screw System Classification Name(s): Plate, Bone Regulatory Class: Class II; 872.4760 Product Code(s): JEY #### 1.3. Predicate Device K082335 Synthes MatrixMANDIBLE Plate and Screw System #### Device Description 1.4. The DePuy Synthes MatrixMANDIBLE Plate and Screw System incorporates small, medium and large plates designed so all plates accept all system screws. The plates are available in various shapes and thicknesses and accept self-tapping and self-drilling cortex and locking screws. The implants are manufactured from titanium. #### Indications for Use 1.5. The DePuy Synthes MatrixMANDIBLE Plate and Screw System is intended for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). {42}------------------------------------------------ ## Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the DePuy Synthes MatrixMANDIBLE Plate and Screw System. The intended use and technological characteristics…