Product Code: KKY FDA class 2 21 CFR 878.3500

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

General, Plastic Surgery

This material, consisting of polytetrafluoroethylene (PTFE) and vitreous carbon, is used in maxillofacial reconstructive surgery to repair or augment craniofacial bone defects, providing a biocompatible structural framework for facial reconstruction. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance to demonstrate substantial equivalence. The product code is KKY and it is regulated under 21 CFR 878.3500 in the General and Plastic Surgery specialty. This device is an implant.

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FEI Numbers

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Basic Information

Product Code: KKY
Device Class: FDA class 2
Regulation Number: 878.3500
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K211514	Longeviti PorousFit implant	Jul 15, 2021	Substantially Equivalent	Longeviti Neuro Solutions, LLC
K161052	OsteoFab Patient Specific Facial Device	Jul 20, 2016	Substantially Equivalent	Oxford Performance Materials, Inc.
K160988	Biopor, AOC Porous Polyethylene, Cerepor	Jul 14, 2016	Substantially Equivalent	Ceremed , Inc.
K141880	BIOPOR AOC POROUS POLYETHYLENE, CEREPOR	Apr 16, 2015	Substantially Equivalent	Ceremed , Inc.
K133809	OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE	Jul 28, 2014	Substantially Equivalent	Oxford Performance Materials
K140437	SU-POR SURGICAL IMPLANT	Jun 13, 2014	Substantially Equivalent	Poriferous, LLC
K133046	OMNIPORE CUSTOMIZED SURGICAL IMPLANTS	May 14, 2014	Substantially Equivalent	Matrix Surgical Holdings, LLC/Matrix Surgical USA
K123908	OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES	Jul 31, 2013	Substantially Equivalent	Matrix Surgical USA
K111323	SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS	Nov 16, 2011	Substantially Equivalent	Synthes, Inc.
K103010	STRYKER PATIENT SPECIFIC POLYMER IMPLANT	Oct 26, 2010	Substantially Equivalent	Howmedica Osteonics Corp., Dba Stryker Orthopaedics
K080507	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT	Apr 21, 2008	Substantially Equivalent	Ceremed , Inc.
K071937	BONALIVE GRANULES AND BONALIVE PLATES	Oct 19, 2007	Substantially Equivalent	Vivoxid , Ltd.
K043250	STRYKER PATIENT SPECIFIC POLYMER IMPLANT	Apr 15, 2005	Substantially Equivalent	Stryker Leibinger
K043133	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR	Mar 02, 2005	Substantially Equivalent	Ceremed , Inc.
K021889	SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)	Oct 16, 2002	Substantially Equivalent	Surgical Technology Laboratories, Inc.
K022665	POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE	Oct 09, 2002	Substantially Equivalent	Hohenstein Enterprises, Inc.
K013764	IMMIX BONE GRAFT EXTENDER	May 16, 2002	Substantially Equivalent	Osteogenics Biomedical, Inc.
K951474	TLC SURGICAL DRAPES	Aug 18, 1995	Substantially Equivalent	Tlc Tech Lab Clothes, Inc.
K934861	HARD TISSUE REPLACEMENT (HTR) GRANULAR	Nov 04, 1994	Substantially Equivalent	Poly-Medics,Inc.
K935199	SURGICAL APPAREL	Sep 30, 1994	Substantially Equivalent	Associated Hospital Services, Inc.
K924935	HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT	Sep 02, 1993	Substantially Equivalent	Polyclinic Medical Center
K915445	MAALEABLE FACIAL IMPLANT	Feb 03, 1992	Substantially Equivalent	Biomet Ussc Orthopedics
K904111	HTR POLYMER, HTR-MX	Nov 23, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K894478	UHMWPE SURGICAL MESH	Mar 08, 1990	Substantially Equivalent	Biomet, Inc.
K781019	SURG. GOWN & DRAPE, LOW LINT TREATMENT	Aug 14, 1978	Substantially Equivalent	Kimberly-Clark Corp.