MCI - CMF System

{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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. December 5, 2019 MCI Medical Concept Innovation Inc. % Janine Treter Regulatory Affairs Specialist Passarini Regulatory Affairs of America LLC 201 Biscayne Blvd, Suite 1200 Miami, Florida 33131 Re: K182758 Trade/Device Name: MCI - CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 4, 2019 Received: November 6, 2019 # Dear Janine Treter: 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 (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, Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182758 Device Name MCI - CMF System Indications for Use (Describe) MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border:none"><tr><td><div> <span> <svg height="16" width="16"> <polygon points="1 0, 16 0, 16 15, 0 15, 0 0, 1 0" style="fill:lightgrey;stroke:black;stroke-width:1"></polygon> <polyline points="2 2,8 12,14 2" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <span> <svg height="16" width="16"> <polygon points="0 0, 15 0, 15 15, 0 15, 0 0" style="fill:white;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <span> <svg height="16" width="16"> <polygon points="1 0, 16 0, 16 15, 0 15, 0 0, 1 0" style="fill:lightgrey;stroke:black;stroke-width:1"></polygon> <polyline points="2 2,8 12,14 2" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <polygon points="0 0, 15 0, 15 15, 0 15, 0 0" style="fill:white;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> <span> <svg height="16" width="16"> <polygon points="1 0, 16 0, 16 15, 0 15, 0 0, 1 0" style="fill:lightgrey;stroke:black;stroke-width:1"></polygon> <polyline points="2 2,8 12,14 2" style="fill:none;stroke:black;stroke-width:2"></polyline> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="16" width="16"> <polygon points="0 0, 15 0, 15 15, 0 15, 0 0" style="fill:white;stroke:black;stroke-width:1"></polygon> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ # 510(k) Summary # ADMINISTRATIVE INFORMATION | Manufacturer Name | MCI Medical Concept Innovation Inc.<br>4592 North Hiatus Road<br>Sunrise, Florida, USA 33351 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Carlos Lacerda, Mr.<br>Manager Director<br>MCI Medical Concept Innovation Inc.<br>E-Mail: carlos.lacerda@mci-medical.com<br>Telephone +01 (954) 306-2521 | | Date Prepared | 05/Dec/2019 | | Preparer / Alternate Contact | Janine Treter<br>Regulatory Affairs Specialist<br>Passarini Regulatory Affairs<br>janine@rapassarini.com.br | | DEVICE NAME AND CLASSIFICATION | | | Trade/ Proprietary Name | MCI - CMF System | | Common Names | Bone Plate; Fixation Screws | | Primary Classification Name | Bone Plate | | Primary Classification Regulation | 21 CFR 872.4760, Class II | | Primary Product Code | JEY | | Subsequent Classification Name | Intraosseous Fixation Screw or Wire | | Subsequent Classification Regulation | 21 CFR 872.4880, Class II | | Subsequent Product Code | DZL | | Classification Panel | Dental Products Panel | | Reviewing Branch | Dental Devices Branch | | PREDICATE DEVICE INFORMATION | | | Primary Predicate Device | K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare<br>- Visionare LLC | | Reference Devices | K944565 -KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM) - KLS-MARTIN L.P.<br>K943347 - KLS Mini Osteosynthesis System - KLS-MARTIN L.P.<br>K083388 - Synthes MatrixORTHOGNATHIC Plate System - Synthes (USA)<br>K091233 - SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES - SYNTHES (USA) | {4}------------------------------------------------ K022185 - Universal CMF System - Stryker Leibinger K182609 - Delphos Implants Rigid Fixation System - Delphos Implants - Ind. Com. Importação e Exportação K140037 & K160363 - Optimus CMF System - Osteonic Co., Ltd. K050934 - MODUS® Titanium Osteosynthesis System - Medartis Inc. K091679 & K103778 - LeForte Neuro System Bone Plate - Jeil Medical Corporation ### INDICATIONS FOR USE MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. ## SUBJECT DEVICE DESCRIPTION The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery. # TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE The subject and the predicate devices have a range of plates and screws with the same indication for reconstructive surgery, for fixation of maxillofacial and oral fractures, orthognathic reconstructions, mandibular reconstruction and any osteotomy surgery or trauma in maxillofacial. The subject device is substantially equivalent to the primary predicate device K180204 in intended use, Indications for Use, designs, materials, and function. The indication for use statement of the subject devices, primary predicate and reference devices is shown in Table 5.1. The indication for use statement of subject and primary predicate device is identical. A comparison between the design and features of the subject devices, primary predicate and reference devices is shown in tabular format for plates (Tables 5.2 and 5.3) and screws (Table 5.4). The subject device plates are substantially equivalent to the primary predicate device K180204, or reference devices K944565, K943347, K08388, K091233, K022185, K182609, K140037 & K160363, K050934, K091679 & K103778, in designs and range of dimensions. Differences in the plates design features and dimensions between the subject device and the primary predicate device K180204 are addressed by comparison to the reference devices. {5}------------------------------------------------ For System 1.5, the reference device K944565 is for substantial equivalence of part of the Straight Micro Plates, Straight Micro Plates Bridge, L Micro Plates Bridge, and Y Micro Plates Bridge. It is for substantial equivalence of the Orbital Micro Plate L Oblique Bridge, H Nasal Micro Plate, I Nasal Micro Plate, Orbital Floor Micro Mesh and 3D Micro Mesh of 83x83, 122x 122 and 200x200 mm. For System 2.0, the reference device K944565 is for substantial equivalence of part of the Mini Plate Double Pillar for Ment. The reference device K943347 for System 1.5 is for substantial equivalence of T Micro Plate Bridge 4 holes in design only. For System 2.0, the reference device K943347 is for substantial equivalence of L Mini Plates and L Mini Plates Bridge of 6 holes. Both are reversible plates and are covered by two plates of the reference device in the same design (right/left). It is also for substantial equivalence of T Mini Plate Bridge of 4 holes, Straight Mini Plates Bridge Tab, Chin Mini Plates Bridge Tab and L Mini Plates Bridge Double Tab. The reference device K083388 for System 1.5 is for substantial equivalence of part of the Micro Plate Bridge. It is for the substantial equivalence of the Micro Plates L Orbital Oblique Bridge. For system 2.0, this reference device is for substantial equivalence of the Straight Mini Plate of 20 holes, L Mini Plate Oblique Bridge, Sagittal Mini Plates Cut Bridge and Sagittal Mini Plates Cut Oblong Bridge. The reference device K091233 for System 2.0 is for substantial equivalence of Lambda Mini Plates, Support Mini Plates, Trapezoidal Mini Plates and Trapezoidal Parallel Mini Plates. The reference device K022185 for System 1.5 is for substantial equivalence of part of the T Micro Plate Bridge of 5 holes. It is for substantial equivalence of the Orbital Floor Plate. For System 2.0, K022185 is for substantial equivalence of T Mini Plate of 6 holes, T Orbital Mini Plate Bridge, and for the design features not emcopassed by K944595 for the Mini Plate Double Pillar for Ment. The reference device K182609 for System 1.5 is for substantial equivalence of the Straight Micro Plate design features not encompassed by K944565, part of the 4 and 6 holes Straight Micro Plates Bridge and for the design features of the T Micro Plates Bridge 5 holes not completely emcopassed by K022185. The K182609 is also for the substantial equivalence of X Micro Plate Bridge and Support Zygomatic Micro Plates. For System 2.0, the reference device K182609 is for substantial equivalence of the Straight Mini Plate of 6 holes, Straight Mini Plate Bridge of 4 holes and for part of the Straight Mini Plate Bridge of 6 holes. It is for the substantial equivalence of the Orbital Mini Plates of 8 and 10 holes, Y Mini Plate, Mini Plates Double Line Bridge and for substantial equivalence of the Chin Mini Plates not encompassed by the primary predicate device. The reference devices K140037 & K160363 for System 1.5 are for substantial equivalence of the Lefort Micro Plates. For System 2.0 are for substantial equivalence of Straight Mini Plates not emcopassed by K083388 and K182609 and for the Orbital Mini Plate not emcopassed by K182609. The reference devices K140037 & K160363 are also for the substantial equivalence of BSSO Dual Angled Mini Plates Bridge. For System 1.5 the reference device K050934 is for substantial equivalence of the Straight Micro Plate Bridge features not emcopassed by K944565 and K182609, and of the L Micro Plates Bridge features not encompassed by K944565 and K083388. It is also for substantial equivalence of Y Micro Plate Bridge not emcompassed by K944565 and 3D Micro Mesh of 50x50 mm. For System 2.0 is for substantial equivalence of Straight Mini Plates Bridge not emcopassed by K182609 and L Mini Plates {6}------------------------------------------------ Bridge not encompassed by K943347. It is also for the substantial equivalence of the Mini Plate Sagittal. The reference devices K091679 & K103778 for System 1.5 are for substantial equivalence of Angled Micro Plates for Piriformis. The subject device screws are substantially equivalent to the primary predicate device K180204, or reference devices K944565 and K022185, in designs and range of dimensions for all types of screws: Cortical Screw, Emergency Cortical Screw, Cortical Screw AP and Locking Screw AP. Differences in the screw design features and dimensions between the subject device and the primary predicate device K180204 are addressed by comparison to the reference devices. For screws, the reference device K944565 is for substantial equivalence on the results of comparative performance testing. The reference device K022185 is for substantial equivalence of the length 20 mm for Cortical Screws of 2.0 mm diameter and Emergency Cortical Screw of 2.3 mm. The reference device K022185 is also for substantial equivalence of the Cortical Screws AP of 2.0 mm in diameter for the length of 4 mm. {7}------------------------------------------------ | Table 5.1: Comparison on indication for use statement | | | | |------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE<br>DISCUSSION | | SUBJECT<br>DEVICE | K182758 – MCI - CMF System<br><br>MCI Medical Concept Innovation Inc. | MCI - CMF System is intended for use in selective trauma of the midface,<br>maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery<br>of the maxilla, mandible and chin. | Equivalent<br><br>The indication for use of subject and<br>primary predicate device is identical. | | PRIMARY<br>PREDICATE<br>DEVICE | K180204 - CranioMaxillofacial Fixation (CMF) System<br>- CMF Visionare<br><br>Visionare LLC | CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in<br>selective trauma of the midface, maxillofacial surgery, reconstructive procedures,<br>and selective orthognathic surgery of the maxilla, mandible and chin. | The subject device indication for use is<br>within the scope of indications of the<br>reference devices. | | REFERENCE<br>DEVICES | K944565 -KLS-MARTIN MICRO OSTEOSYTHESIS<br>SYSTEM(1.5MM)<br><br>KLS Martin LP | No 510(k) summary available | Despite of the reference devices<br>"K091679 & K103778 - LeForte Neuro<br>System Bone Plate" citing the word<br>Neuro in their proprietary name, by the<br>indication for use itself is possible to<br>understand they remain in the scope<br>since are related to midface and<br>craniomaxillofacial applications.<br>Therefore, K091679 & K103778 are<br>suitable as reference predicates. | | | K943347 - KLS Mini Osteosynthesis System<br><br>KLS-MARTIN L.P. | No 510(k) summary available | | | | K083388- Synthes MatrixORTHOGNATHIC Plating<br>System | The Synthes MatrixORTHOGNATHIC Plating System is intended for use in selective<br>trauma of the midface and craniofacial skeleton; craniofacial surgery; | | | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE<br>DISCUSSION | | | Synthes (USA) | reconstructive procedures; and selective orthognathic surgery of the maxilla,<br>mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. | | | | | Specific Indications for Use: | | | | | • Fractures ofthe midface and craniofacial skeleton | | | | | • LeFort I osteotomies, sagittal split osteotomies and genioplasties | | | | | • Orthognathic surgery including reconstructive procedures | | | | K091233 - SYNTHES MATRIXMANDIBLE<br>SUBCONDYLAR PLATES | The Synthes MatrixMANDIBLE Subcondylar Plates are intended for oral,<br>maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of<br>the subcondylar region of the mandible and fractures of the condylar basis region of<br>the mandible. | | | | SYNTHES (USA) | | | | | K022185 - Universal CMF System | The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate<br>and screw system intended for osteotomy, stabilization and rigid fixation of CMF<br>fractures and reconstruction. | | | | Stryker Leibinger | | | | | REFERENCE<br>DEVICES | K182609 - Delphos Implants Rigid Fixation System<br>Delphos Implants - Ind. Com. Importação e<br>Exportação | The Delpos Implants Rigid Fixation System is intended for fracture fixation in<br>maxillofacial trauma reconstruction, mandibular reconstruction and orthognatic<br>reconstruction. | | | KNUMBER/ MANUFACTURER | INDICATION FOR USE STATEMENT | SUBSTANTIAL EQUIVALENCE<br>DISCUSSION | | | | The Delpos Implants Rigid Fixation System implants are intended for single use only. | | | | K140037 & K160363 - Optimus CMF System<br>Osteonic Co., Ltd. | Optimus CMF System is implantable bone plates and bone screws for maxillofacial<br>and mandible surgery procedures including:<br>1. Fractures<br>2. Osteotomies<br>3. Reconstructive procedures<br>4. Revision procedures where other treatments or devices have failed. | | | | K050934 - MODUS® Titanium Osteosynthesis System<br>Medartis, Inc. | The MODUS® Titanium Osteosynthesis System is intended for osteotomies and<br>fractures involving any part ofthe craniofacial skeleton and requiring positional and<br>functional stability. Indications include fixation in the nasoethmoidal, intraorbital,<br>and frontal sinus areas; fixation of comminuted fractures of maxillo-facial and<br>craniofacial areas; tumor surgery for defect bridging; reconstruction of bony<br>structures by means of mesh materials; coverings for burr holes in the skull; trauma<br>of nasal bones; surgical correction of dento facial deformations; and reconstruction<br>after tumor surgery. | | | | K091679 & K103778 - LeForte Neuro System Bone<br>Plate<br>Jeil Medical Corporation | This device is intended for use in selective trauma of the mid-face and craniofacial<br>skeleton; craniofacial surgery; reconstructive procedures; and selective orthognatic<br>surgery of the maxilla and chin. | | | MCI Medical Concept Innovation Inc. {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ### Table 5.2: Comparison between the subject, primary and reference K944565. K943347. K083388. K091233 devices for plates to be optived | COMPARISON | SUBJECT DEVICE | | | PRIMARY PREDICATE DEVICE | | | REFERENCE DEVICES | | | | | | | | | | | | |-------------------|------------------------------------------|--------------------------------------|-------------------|----------------------------------|-------------------------|-------------------|------------------------------------------|-----------------------------|-------------------|------------------------------|-------------|-------------------|---------------------------|---------|-------------------|-------------|---------|-------------------| | | K182758 | | | K180204 | | | K944565 | | | K943347 | | | K083388 | | | K091233 | | | | Product Code | JEY, DZL | | | JEY, DZL | | | JEY | | | JEY | | | JEY, DZL | | | JEY | | | | Raw Material | CP Titanium | | | CP Titanium | | | CP Titanium | | | CP Titanium | | | CP Titanium | | | CP Titanium | | | | Surface treatment | Anodized | | | Anodized | | | Anodized | | | Anodized | | | Anodized | | | Anodized | | | | | System 1.5 | | | | | | | | | | | | | | | | | | | Design/Features | Description | Hole nº | Thickness (mm) | Description | Hole nº | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | Description | Holes | Thickness (mm) | | | Straight Micro Plate | 4, 6, 8, 10, 16, 20 | 0.6 | Straight Mini Plate Regular | 4, 6, 8, 16, 20 | 0.7 | Micro Plate | 4, 6, 8, 16, 20 | 0.6 | Mini Plate | 4, 6, 8, 16 | 0.6, 1.0 | | | | | | | | | Straight Micro Plate Bridge | 4, 6 | 0.6 | Straight Mini Plate Medium | 4, 6 | 0.7 | Micro Plate | 4, 6 | 0.6 | | | | | | | | | | | | Orbital Micro Plate | 8, 10 | 0.6 | Orbital Mini Plate Regular | 8, 10 | 0.7 | Micro Plate | 8, 10 | 0.6 | Champy Plate | 8, 10 | 0.6 | | | | | | | | | L Micro Plate Bridge | 4 | 0.6 | L Mini Plate Medium & Extra Long | 4 | 0.7 | Micro Plate | 4 | 0.6 | Mini Plate | 4 | 0.6, 1.0 | 90° L Plate Medium & Long | 4 | 0.5 | | | | | | L Micro Plate Oblique Bridge | 4, 5 | 0.6 | | | | Micro Plate | 4, 5 | 0.6 | | | | | | | | | | | | L Micro Plate Orbital | 6 | 0.6, 0.7, 0.8 | | | | | | | | | | Anatomical L Plate | 6 | 0.5, 0.7, 0.8 | | | | | | T Micro Plate Bridge | 4, 5 | 0.6 | T Mini Plate Medium & Extra Long | 5 | 0.7 | | | | Champy Plate | 4 | 1.0 | | | | | | | | | X Micro Plate Bridge | 6 | 0.6 | T Mini Plate Medium & Extra Long | 6 | 0.7 | Micro Plate | 6 | 0.6 | | | | | | | | | | | | Y Micro Plate Bridge | 5 | 0.6 | | | | Micro Plate | 5 | 0.6 | | | | | | | | | | | | Lefort Micro Plate | 11 | 0.6 | | | | Lindorf Micro Le Fort I Plate | 11 | 1.0 | | | | | | | | | | | | Angled Micro Plate Piriforms | 10 | 0.8 | Le Fort Mini Plate | 14 | 0.8 | | | | | | | | | | | | | | | Support Zygomatic Micro Plate | 7 | 0.8 | | | | | | | | | | | | | | | | | | H Nasal Micro Plate | 12 | 0.6 | | | | Micro Plate | 12 | 0.6 | Mini Plate | 12 | 0.6 | | | | | | | | | I Nasal Micro Plate | 11, 12 | 0.6 | | | | Micro Plate | 11, 12 | 0.6 | | | | | | | | | | | COMPARISON | SUBJECT DEVICE | | | PRIMARY PREDICATE DEVICE | | | REFERENCE DEVICES | | | | | | | | | | | | | | | K182758 | | | K180204 | | | K944565 | | | K943347 | | | K083388 | | | K091233 | | | Design/Features | Orbital Floor<br>Micro Mesh | | | | | | Micro Orbital<br>Mesh | | | | | | | | | | | | | | | --- | 0.3, 0.5 | | | | | --- | 0.3, 0.5 | | | | | | | | | | | | Orbital Floor | | | | | | | | | | | | | | | | | | | | Plate | --- | 0.3 | | | | | | | | | | | | | | | | | | 3D Micro Mesh | | | | | | 3D-Mesh | | | | | | | | | | | | | | | 50x50<br>83x83<br>122x122<br>200x200 | 0.6 | | | | | 80x80<br>120x120<br>200x200 | 0.6 | | | | | | | | | | | | System 2.0 | | | | | | | | | | | | | | | | | | | Design/Features | Description | Hole n° | Thickness<br>(mm) | Description | Hole n° | Thickness<br>(mm) | Description | Holes | Thickness<br>(mm) | Description | Holes | Thickness<br>(mm) | Description | Holes | Thickness<br>(mm) | Description | Holes | Thickness<br>(mm) | | | Straight Mini<br>Plate | | | Straight Mini<br>Plate Regular | | | | | | | | | Adaptation<br>Plate | | | | | | | | | 4, 6, 12, 16,<br>20 | 0.9 | | 4, 6, 12,<br>16, 20 | 1.0 | | | | | | | | 20 | 0.8 | | | | | | Straight Mini<br>Plate Bridge | | | Straight Mini<br>Plate Bridge | | | | | | Mini Plate<br>Bridge | | | | | | | | | | | | 4, 6 | 0.9 | | 4, 6 | 1.0 | | | | | 4 | 1.0 | | | | | | | | | Orbital Mini<br>Plate | | | Orbital Mini Plate | | | | | | Champy Plate<br>Bridge | | | | | | | | | | | | 6, 8, 10 | 0.9 | | 6, 8, 10 | 1.0 | | | | | 8, 10 | 0.6 | | | | | | | | | | L Mini Plate | | | L Mini Plate<br>Regular | | | | | | Mini Plate | | | | | | | | | | | 4, 6 | 1.0 | | 4 | 1.0 | | | | | 4, 5 | 1.0 | | | | | | | | | L Mini Plate<br>Bridge | | | L Mini Plate Long | | | | | | Mini Plate | | | | | | | | | | | | 4, 6 | 1.0 | | 4 | 1.0 | | | | | 6 | 1.0 | | | | | | | | | L Mini Plate<br>Oblique Bridge | | | | | | | | | | | | Oblique L Plate | | | | | | | | | 6 | 1.0 | | | | | | | | | | | 6 | 0.8 | | | | | | T Mini Plate | | | | | | | | | Mini Plate | | | | | | | | | | | | 4 | 1.0 | | | | | | | | 4, 6 | 1.0 | | | | | | | | | | 6 | 0.9 | | | | | | | | | | | | | | | | | | T Orbital Mini<br>Plate | | | | | | | | | | | | | | | | | | | | | 8 | 0.9 | | | | | | | | | | | | | | | | | | Y Mini Plate | | | |…