Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500) → KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction # KKY · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction _General, Plastic Surgery · 21 CFR 878.3500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY ## Overview - **Product Code:** KKY - **Device Name:** Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction - **Regulation:** [21 CFR 878.3500](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3500) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **Implant:** yes ## Identification A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K211514](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K211514.md) | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | Jul 15, 2021 | SESE | | [K161052](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K161052.md) | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | Jul 20, 2016 | SESE | | [K160988](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K160988.md) | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed , Inc. | Jul 14, 2016 | SESE | | [K141880](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K141880.md) | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Ceremed , Inc. | Apr 16, 2015 | SESE | | [K133809](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K133809.md) | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | Oxford Performance Materials | Jul 28, 2014 | SESE | | [K140437](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K140437.md) | SU-POR SURGICAL IMPLANT | Poriferous, LLC | Jun 13, 2014 | SESE | | [K133046](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K133046.md) | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | Matrix Surgical Holdings, LLC/Matrix Surgical USA | May 14, 2014 | SESE | | [K123908](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K123908.md) | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | Matrix Surgical USA | Jul 31, 2013 | SESE | | [K111323](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K111323.md) | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | Synthes, Inc. | Nov 16, 2011 | SESE | | [K103010](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K103010.md) | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 26, 2010 | SESE | | [K080507](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K080507.md) | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT | Ceremed , Inc. | Apr 21, 2008 | SESE | | [K071937](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K071937.md) | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | Oct 19, 2007 | SESE | | [K043250](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K043250.md) | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Stryker Leibinger | Apr 15, 2005 | SESE | | [K043133](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K043133.md) | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR | Ceremed , Inc. | Mar 2, 2005 | SESE | | [K021889](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K021889.md) | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | Surgical Technology Laboratories, Inc. | Oct 16, 2002 | SESE | | [K022665](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K022665.md) | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE | Hohenstein Enterprises, Inc. | Oct 9, 2002 | SESE | | [K013764](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K013764.md) | IMMIX BONE GRAFT EXTENDER | Osteogenics Biomedical, Inc. | May 16, 2002 | SESE | | [K951474](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K951474.md) | TLC SURGICAL DRAPES | Tlc Tech Lab Clothes, Inc. | Aug 18, 1995 | SESE | | [K934861](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K934861.md) | HARD TISSUE REPLACEMENT (HTR) GRANULAR | Poly-Medics,Inc. | Nov 4, 1994 | SESE | | [K935199](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY/K935199.md) | SURGICAL APPAREL | Associated Hospital Services, Inc. | Sep 30, 1994 | SESE | ## Top Applicants - Ceremed , Inc. — 4 clearances - Associated Hospital Services, Inc. — 1 clearance - Biomet Ussc Orthopedics — 1 clearance - Biomet, Inc. — 1 clearance - Hohenstein Enterprises, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/KKY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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