KKY · Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
General, Plastic Surgery · 21 CFR 878.3500 · Class 2
Overview
| Product Code | KKY |
|---|---|
| Device Name | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Regulation | 21 CFR 878.3500 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | Longeviti PorousFit implant | Longeviti Neuro Solutions, LLC | Jul 15, 2021 | SESE |
| K161052 | OsteoFab Patient Specific Facial Device | Oxford Performance Materials, Inc. | Jul 20, 2016 | SESE |
| K160988 | Biopor, AOC Porous Polyethylene, Cerepor | Ceremed , Inc. | Jul 14, 2016 | SESE |
| K141880 | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | Ceremed , Inc. | Apr 16, 2015 | SESE |
| K133809 | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | Oxford Performance Materials | Jul 28, 2014 | SESE |
| K140437 | SU-POR SURGICAL IMPLANT | Poriferous, LLC | Jun 13, 2014 | SESE |
| K133046 | OMNIPORE CUSTOMIZED SURGICAL IMPLANTS | Matrix Surgical Holdings, LLC/Matrix Surgical USA | May 14, 2014 | SESE |
| K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES | Matrix Surgical USA | Jul 31, 2013 | SESE |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | Synthes, Inc. | Nov 16, 2011 | SESE |
| K103010 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 26, 2010 | SESE |
| K080507 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT | Ceremed , Inc. | Apr 21, 2008 | SESE |
| K071937 | BONALIVE GRANULES AND BONALIVE PLATES | Vivoxid , Ltd. | Oct 19, 2007 | SESE |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Stryker Leibinger | Apr 15, 2005 | SESE |
| K043133 | AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR | Ceremed , Inc. | Mar 2, 2005 | SESE |
| K021889 | SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) | Surgical Technology Laboratories, Inc. | Oct 16, 2002 | SESE |
| K022665 | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE | Hohenstein Enterprises, Inc. | Oct 9, 2002 | SESE |
| K013764 | IMMIX BONE GRAFT EXTENDER | Osteogenics Biomedical, Inc. | May 16, 2002 | SESE |
| K951474 | TLC SURGICAL DRAPES | Tlc Tech Lab Clothes, Inc. | Aug 18, 1995 | SESE |
| K934861 | HARD TISSUE REPLACEMENT (HTR) GRANULAR | Poly-Medics,Inc. | Nov 4, 1994 | SESE |
| K935199 | 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
