Atlas FDA

KKY

25 FDA 510(k) clearances · Product code

141 daysmedian time to decision
337 days90th percentile
25clearances measured

FDA profile

Official device name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3500
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2015: 18 · 2016: 25 · 2017: 19 · 2018: 17 · 2019: 20 · 2020: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Longeviti PorousFit implant (K211514)Longeviti Neuro Solutions, LLC2021-07-15
OsteoFab Patient Specific Facial Device (K161052)Oxford Performance Materials, Inc.2016-07-20
Biopor, AOC Porous Polyethylene, Cerepor (K160988)Ceremed , Inc.2016-07-14
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR (K141880)Ceremed , Inc.2015-04-16
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE (K133809)Oxford Performance Materials2014-07-28
SU-POR SURGICAL IMPLANT (K140437)Poriferous, LLC2014-06-13
OMNIPORE CUSTOMIZED SURGICAL IMPLANTS (K133046)Matrix Surgical Holdings, LLC/Matrix Surgical USA2014-05-14
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES (K123908)Matrix Surgical USA2013-07-31
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS (K111323)Synthes, Inc.2011-11-16
STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K103010)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2010-10-26
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT (K080507)Ceremed , Inc.2008-04-21
BONALIVE GRANULES AND BONALIVE PLATES (K071937)Vivoxid , Ltd.2007-10-19
STRYKER PATIENT SPECIFIC POLYMER IMPLANT (K043250)Stryker Leibinger2005-04-15
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR (K043133)Ceremed , Inc.2005-03-02
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (K021889)Surgical Technology Laboratories, Inc.2002-10-16
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE (K022665)Hohenstein Enterprises, Inc.2002-10-09
IMMIX BONE GRAFT EXTENDER (K013764)Osteogenics Biomedical, Inc.2002-05-16
TLC SURGICAL DRAPES (K951474)Tlc Tech Lab Clothes, Inc.1995-08-18
HARD TISSUE REPLACEMENT (HTR) GRANULAR (K934861)Poly-Medics,Inc.1994-11-04
SURGICAL APPAREL (K935199)Associated Hospital Services, Inc.1994-09-30
HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (K924935)Polyclinic Medical Center1993-09-02
MAALEABLE FACIAL IMPLANT (K915445)Biomet Ussc Orthopedics1992-02-03
HTR POLYMER, HTR-MX (K904111)United States Surgical, A Division of Tyco Healthc1990-11-23
UHMWPE SURGICAL MESH (K894478)Biomet, Inc.1990-03-08
SURG. GOWN & DRAPE, LOW LINT TREATMENT (K781019)Kimberly-Clark Corp.1978-08-14

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Every clearance here is in the API, with alerts when new ones post.