DePuy Synthes Plates and Screws Portfolio

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date June 21, 2019. The text is in a simple, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is black against a white background. DePuy Synthes Quinn McCarthy Regulatory Affairs Specialist II 1301 Goshen Parkway West Chester, Pennsylvania 19380 Re: K190750 Trade/Device Name: see page 3, List of Cleared Devices in K190750 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, KTT, KTW, LXT, JDO, JDP Dated: March 22, 2019 Received: March 25, 2019 Dear Ouinn McCarthy: 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. 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 {1}------------------------------------------------ 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 (QS) 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, Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure: List of Cleared Devices in K190750 {2}------------------------------------------------ # List of Cleared Devices in K190750 - 1. DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension MR Conditional - 2. DePuy Synthes 3.5 mm Quadrilateral Surface Plates MR Conditional - 3. DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates -MR Conditional - 4. DePuy Synthes 3.5 mm LCP Posteromedial Proximal Tibia Plate 10H/183mm -MR Conditional - 5. DePuy Synthes TornoFiX Medial Distal Femur Plates MR Conditional - 6. DePuy Synthes 3.5mm LCP Distal Tibia T Plates MR Conditional - 7. DePuy Synthes 2.4/2.7 mm Locking Foot Module MR Conditional - 8. DePuy Synthes LCP Distal Femur Plates MR Conditional - 9. DePuy Synthes LCP Ankle Arthrodesis Plates MR Conditional - 10. DePuy Synthes LCP Proximal Tibia Plates Line Extension MR Conditional - 11. DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates MR Conditional - 12. DePuy Synthes LCP Modular Foot Plates MR Conditional - 13. DePuy Synthes LCP Dynamic Helical Hip System MR Conditional - 14. DePuy Synthes LCP Proximal Femur Hook Plates MR Conditional - 15. DePuy Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate MR Conditional - 16. DePuy Synthes LCP Proximal Femur Plate and Screws MR Conditional - 17. DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate MR Conditional - 18. DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System MR Conditional - 19. DePuy Synthes Locking Compression Plate System- MR Conditional - 20. DePuy Synthes LCP Distal Tibia Plates MR Conditional - 21. DePuy Synthes LCP Proximal Tibia Plate MR Conditional - 22. DePuy Synthes Modular Foot System 2.7 mm Module MR Conditional - 23. DePuy Synthes Medial Distal Tibia Plates MR Conditional - 24. DePuy Synthes Modular Foot System- MR Conditional - 25. DePuv Synthes Locking Calcaneal Plates MR Conditional - 26. DePuy Synthes Proximal Tibia Plating System MR Conditional - 27. DePuy Synthes DHS/DCS System Modification MR Conditional - 28. DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System MR Conditional - 29. DePuy Synthes Dynamic Hip Screw MR Conditional - 30. DePuy Synthes 2.7 mm Condylar Plate- MR Conditional {3}------------------------------------------------ 510(k) Number (if known) K190750 ### Device Name DePuy Synthes Modular Mini Fragment LCP System - MR Conditional Indications for Use (Describe) The DePuy Synthes Modular Mini Fragment LCP System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. | 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 {4}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension - MR Conditional Indications for Use (Describe) The DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar and extra-atticular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions. 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 {5}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 3.5MM QUADRILATERAL SURFACE PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes 3.5mm Quadrilateral Surface Plates for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates. Type of Use (Select one or both, as applicable) | <span style="font-family:Wingdings;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family:Wingdings;"> </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 {6}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES - MR Conditional Indications for Use (Describe) The DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. Type of Use (Select one or both, as applicable) | <span style="font-family:Wingdings;"> </span> <span style="font-family:Arial;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family:Wingdings;">□</span> <span style="font-family:Arial;">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) K190750 Device Name DePuy Synthes 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE 10H/183MM - MR Conditional Indications for Use (Describe) DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of the proximal, distal, and metaphyseal areas of the tibia. Type of Use (Select one or both, as applicable) | <div><span style="font-size:100%;"> Prescription Use (Part 21 CEB 801 Subpart D)</span></div> | |---------------------------------------------------------------------------------------------------| | <div><span style="font-size:100%;"> Over-The-Counter Use (21 CER 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 {8}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes TOMOFIX MEDIAL DISTAL FEMUR PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes TornoFiX Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</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 {9}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 3.5MM LCP DISTAL TIBIA T PLATES - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Distal Tibia T Plates are indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone. 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 {10}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 2.4/2.7 MM LOCKING FOOT MODULE - MR Conditional Indications for Use (Describe) The DePuy Synthes 2.4/2.7 mm Locking Foot Module is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, including the foot and ankle, particularly in osteopenic bone. | 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 {11}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP DISTAL FEMUR PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprostheic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>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 {12}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP ANKLE ARTHRODESIS PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia. 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) K190750 Device Name DePuy Synthes LCP PROXIMAL TIBIA PLATES LINE EXTENSION - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Proximal Tibia System is intended for treatment of nonunions, osteopenic bone, tibial osteotornies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CFR 801 Subpart D)</b></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 {14}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES - MR Conditional ### Indications for Use (Describe) The DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia shaft, as well as opening and closing wedge tibial osteotomnies. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ 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 {15}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP MODULAR FOOT PLATES - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, reconstructive procedures and replantations of small bones including the foot and ankle. | Type of Use (Select one or both, as applicable) | | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | <table border="0"><tr><td><table border="0"><tr><td><span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr></table></td><td><table border="0"><tr><td><span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table></td></tr></table> | <table border="0"><tr><td><span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr></table> | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <table border="0"><tr><td><span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | <table border="0"><tr><td><span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr></table> | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <table border="0"><tr><td><span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | | <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 {16}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP DYNAMIC HELICAL HIP SYSTEM - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | <div><span style="font-family: Arial;"></span> <span style="font-family: DejaVu Sans, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-family: Arial;"></span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C)</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 {17}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP PROXIMAL FEMUR HOOK PLATES - MR Conditional ### Indications for Use (Describe) The DePuy Synthes LCP Proximal Femur Hook Plates are intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of the proximal end of the femur combined with ispsilateral shaft fractures of the proximal femur and osteotomies of the proximal femur. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"></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 {18}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE - MR Conditional Indications for Use (Describe) DePuy Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula. | 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 {19}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP PROXIMAL FEMUR PLATE AND SCREWS - MR Conditional Indications for Use (Describe) DePuy Synthes LCP Proximal Femur Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of the proximal end of the femur combined with ispsilateral shaft fractures of the proximal femur and osteotomies of the proximal femur. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | XI 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 {20}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate is intended for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">X</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 {21}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM - MR Conditional Indications for Use (Describe) The DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <span style="font-family:Wingdings;"> occhio-di-lince-1000.jpg</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 {22}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP DISTAL TIBIA PLATES - MR Conditional Indications for Use (Describe) The DePuy Synthes Locking Compression Plate (LCP) System is intended for fixation of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. The DePuy Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the DePuy Synthes Small Fragment LCP System. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> 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 {23}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LCP PROXIMAL TIBIA PLATE - MR Conditional Indications for Use (Describe) The DePuy Synthes LCP Proximal Tibia Plate is intended for treatment of non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-size:16px">☑</span> 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 {24}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes MODULAR FOOT SYSTEM - 2.7 MM MODULE - MR Conditional Indications for Use (Describe) The DePuy Synthes Modular Foot System - 2.7 mm Module is intended for fractures, osteotomies, fusions and replantations of small bones including the foot, ankle, and hand. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px;">☐</span> 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 {25}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes MEDIAL DISTAL TIBIA PLATES- MR Conditional Indications for Use (Describe) DePuy Synthes Medial Distal Tibia Plates are indicated for the fixation of the distal tibia including, but not limited to, ankle fractures, periarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures. | 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) Number (if known) K190750 Device Name DePuy Synthes Modular Foot System- MR Conditional Indications for Use (Describe) DePuy Synthes Modular Foot System is intended for fractures, and replantations of small bones including the foot, ankle, and hand. | 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 {27}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LOCKING CONDYLAR PLATE (LCP) SYSTEM- MR Conditional Indications for Use (Describe) The DePuy Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions. Type of Use (Select one or both, as applicable) | <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </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 {28}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes LOCKING CALCANEAL PLATES - MR Conditional Indications for Use (Describe) DePuy Synthes Locking Calcaneal Plates are indicated for fractures of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures. | 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 {29}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes PROXIMAL TIBIA PLATING SYSTEM - MR Conditional Indications for Use (Describe) The DePuy Synthes Proximal Tibia Plating System is intended for non-unions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. 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 {30}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes DHS/DCS SYSTEM MODIFICATION - MR Conditional Indications for Use (Describe) DePuy Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |--------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart C) </span> | | > 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 {31}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM - MR Conditional Indications for Use (Describe) DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. Type of Use (Select one or both, as applicable) | <span style="font-size: 10px;"> <svg height="10" width="10"> <rect height="10" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10px;"> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></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 {32}------------------------------------------------ 510(k) Number (if known) K190750 Device Name DePuy Synthes DYNAMIC HIP SCREW - MR Conditional Indications for Use (Describe) The DePuy Synthes DHS is indicated for the following fractures of the proximal femur: · Intertrochanteric fractures - · Subtrochanteric fractures · Basilar neck fractures The DHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed. | 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 {33}------------------------------------------------ #### 510(k) Summary 1. Date Prepared: March 22, 2019 #### 1.1. Submitter ## Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6730 qmccarth@its.jnj.com ## Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com #### 1.2. Device Name of Device: DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension – MR Conditional Classification Name(s): Condylar Plate Fixation Implant Regulatory Class: Class II Product Code(s): JDP, HWC #### 1.3. Predicate Device K162124 - Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension #### 1.4. Device Description The DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System consists of anatomicallycontoured, stainless steel and titanium plates and screws featuring variable angle locking and combi-holes designed to provide stable fixation of the distal femur and system specific instrumentation. The current 510(k) introduces OPTILINK™ Technology stainless steel screws, positioning pins for cerclage cable, and system specific instrumentation as a line extension to the currently cleared Synthes 4.5mm VA LCP Curved Condylar Plate System. #### 1.5. Indications for Use {34}------------------------------------------------ The DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extraarticular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions. #### 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the K162124. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension 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 non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {35}------------------------------------------------ #### 510(k) Summary 1. Date Prepared: March 22, 2019 #### 1.1. Submitter # Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6730 qmccarth@its.jnj.com # Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com #### 1.2. Device Name of Device: DePuy Synthes 3.5mm Quadrilateral Surface Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS #### 1.3. Predicate Device ### K093928 - SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES #### 1.4. Device Description DePuy Synthes 3.5mm Quadrilateral Surface Plates consist of metallic plates pre-shaped to fit the quadrilateral surface of the pelvis. The plates are provided in shodt, standard, and long versions. #### 1.5. Indications for Use DePuy Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates. {36}------------------------------------------------ #### 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the K093928. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5mm Quadrilateral Surface 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 non-clinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {37}------------------------------------------------ #### 510(k) Summary 1. Date Prepared: March 22, 2019 #### 1.1. Submitter ## Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6730 qmccarth@its.jnj.com ## Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com #### 1.2. Device Name of Device: DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS, HWC - 1.3. Predicate Device # K083213 - SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES #### 1.4. Device Description DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm locking screws along with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths. 1.5. Indications for Use {38}------------------------------------------------ The DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula, especially in osteopenic bone. #### Substantial Equivalence 1.6. The purpose of this submission is to add MR Conditional information to the device labeling for the K083213. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula 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 nonclinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {39}------------------------------------------------ #### 510(k) Summary 1. Date Prepared: March 22, 2019 #### 1.1. Submitter ### Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6730 qmccarth@its.jnj.com ## Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com #### 1.2. Device Name of Device: DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS #### 1.3. Predicate Device K082624 - SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES #### 1.4. Device Description The DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are pre-contoured bone fixation plates intended for the treatment of fractures of the tibia. The plates are offered sterile and non-sterile and are available in stainless steel and titanium. #### 1.5. Indications for Use DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of the proximal, distal, and metaphyseal areas of the tibia. {40}------------------------------------------------ #### 1.6. Substantial Equivalence The purpose of this submission is to add MR Conditional information to the device labeling for the K082624. The intended use and technological characteristics of the devices remains unchanged. Non-clinical testing is provided to support the conditional safety of the DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia 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 nonclinical performance data demonstrate that the subject devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. {41}------------------------------------------------ #### 510(k) Summary 1. Date Prepared: March 22, 2019 #### 1.1. Submitter # Primary Contact: Quinn McCarthy Regulatory Affairs Specialist II DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-6730 qmccarth@its.jnj.com # Alternate Contact: Elizabeth Jacobs Regulatory Affairs Project Leader DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 Phone: (610) 719-5768 Ejacob10@its.jnj.com #### 1.2. Device Name of Device: DePuy Synthes TomnoFiX Medial Distal Femur Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s…