Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KKY — Predicate Candidate Screening

25 FDA 510(k) clearances under this product code; the 50 most recent screened below.

141 daysmedian FDA review time

337 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K211514	Longeviti PorousFit implant	Longeviti Neuro Solutions, LLC	2021-07-15	59	0
K161052	OsteoFab Patient Specific Facial Device	Oxford Performance Materials, Inc.	2016-07-20	97	0
K160988	Biopor, AOC Porous Polyethylene, Cerepor	Ceremed , Inc.	2016-07-14	97	0
K141880	BIOPOR AOC POROUS POLYETHYLENE, CEREPOR	Ceremed , Inc.	2015-04-16	279	0
K133809	OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE	Oxford Performance Materials	2014-07-28	224	0
K140437	SU-POR SURGICAL IMPLANT	Poriferous, LLC	2014-06-13	112	0
K133046	OMNIPORE CUSTOMIZED SURGICAL IMPLANTS	Matrix Surgical Holdings, LLC/Matrix Surgical USA	2014-05-14	229	1
K123908	OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES	Matrix Surgical USA	2013-07-31	224	1
K111323	SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPL	Synthes, Inc.	2011-11-16	189	0
K103010	STRYKER PATIENT SPECIFIC POLYMER IMPLANT	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	2010-10-26	14	1
K080507	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETH	Ceremed , Inc.	2008-04-21	56	0
K071937	BONALIVE GRANULES AND BONALIVE PLATES	Vivoxid , Ltd.	2007-10-19	98	0
K043250	STRYKER PATIENT SPECIFIC POLYMER IMPLANT	Stryker Leibinger	2005-04-15	143	4
K043133	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETH	Ceremed , Inc.	2005-03-02	110	0
K021889	SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)	Surgical Technology Laboratories, Inc.	2002-10-16	131	0
K022665	POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIO	Hohenstein Enterprises, Inc.	2002-10-09	61	0
K013764	IMMIX BONE GRAFT EXTENDER	Osteogenics Biomedical, Inc.	2002-05-16	184	0
K951474	TLC SURGICAL DRAPES	Tlc Tech Lab Clothes, Inc.	1995-08-18	141	0
K934861	HARD TISSUE REPLACEMENT (HTR) GRANULAR	Poly-Medics,Inc.	1994-11-04	388	0
K935199	SURGICAL APPAREL	Associated Hospital Services, Inc.	1994-09-30	338	0
K924935	HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT	Polyclinic Medical Center	1993-09-02	337	0
K915445	MAALEABLE FACIAL IMPLANT	Biomet Ussc Orthopedics	1992-02-03	60	0
K904111	HTR POLYMER, HTR-MX	United States Surgical, A Division of Tyco Healthc	1990-11-23	78	0
K894478	UHMWPE SURGICAL MESH	Biomet, Inc.	1990-03-08	233	0
K781019	SURG. GOWN & DRAPE, LOW LINT TREATMENT	Kimberly-Clark Corp.	1978-08-14	210	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda