Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

HRY — Predicate Candidate Screening

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

84 daysmedian FDA review time

255 days90th percentile

91clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K193549	SIGMA High Performance (HP) Partial Knee System	Depuy Ireland UC	2020-04-16	118	0
K190633	NanoOrtho NanoKnee® System	Nanoortho, LLC	2019-12-20	283	0
K152631	MPO Total Knee Systems MR Labeling	Microport Orthopedics, Inc.	2016-03-23	190	0
K150410	RESTORIS POROUS PARTIAL KNEE SYSTEM	Mako Surgical Corporation	2015-03-20	30	0
K133940	OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARI	Biomet UK, Ltd.	2014-03-28	95	3
K131167	UNIVATION	Aesculap Implant Systems, LLC	2013-10-17	176	0
K122277	OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFOR	Biomet Manufacturing Corp	2012-10-22	84	30
K110415	SIGNATURE PLANNER / SIGNATURE GUIDES	Materialise NV	2011-05-16	91	1
K100973	EVOLUTION UNICONDYLAR KNEE SYSTEM	Wrightmedicaltechnologyinc	2010-08-10	124	0
K082567	STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION	Howmedica Osteonics Corp.	2008-10-03	29	0
K081293	UNIVATION UNICONDYLAR KNEE SYSTEM	Aesculap Implant Systems, Inc.	2008-09-22	138	0
K072704	UNICOMPARTMENTAL KNEE	Valpo Orthopedic Technology, Inc.	2008-02-19	148	0
K071881	TRIATHLON PKR SYSTEM	Howmedica Osteonics Corp.	2007-10-09	92	1
K070267	DEPUY GCK TIBIAL COMPONENTS	DePuy Orthopaedics, Inc.	2007-08-17	200	0
K063515	TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR	Biomet Manufacturing, Inc.	2007-02-02	73	0
K061681	REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING	Biomet Manufacturing Corp	2006-10-19	126	0
K060412	ACTIVE UNICOMPARTMENTAL KNEE SYSTEM	Australian Surgical Design & Manufacture	2006-05-17	90	0
K053299	REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT	Biomet Manufacturing, Inc.	2006-01-05	41	0
K051721	GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM	Global Orthopaedic Technology, USA, Inc.	2005-10-26	121	0
K050764	UNIGLIDE UNICONDYLAR KNEE PROSTHESIS	Corin USA	2005-08-24	153	0
K042093	VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS	Biomet, Inc.	2004-11-01	90	1
K040889	EXACTECH OPTETRAK UNICONDYLAR KNEE	Exactech, Inc.	2004-10-01	179	1
K040268	DEPUY PRESERVATION UNICONDYLAR TIBIA	DePuy Orthopaedics, Inc.	2004-05-05	90	10
K033351	GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE	Global Orthopaedic Technology, USA, Inc.	2004-03-11	143	0
K033810	NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM	Centerpulse Orthopedics, Inc.	2004-03-05	88	1
K032052	UC-PLUS SOLUTION UNICONDYLAR KNEE	Plus Orthopedics	2003-07-25	23	1
K030446	REPICCI LOCKED KEEL TIBIAL BEARING	Biomet, Inc.	2003-03-06	23	0
K030193	ADVANCE LESS CONFORMING TIBIAL COMPONENT	Wrightmedicaltechnologyinc	2003-02-20	30	0
K022437	UNI KNEE	Encore Medical L.P.	2002-08-23	29	2
K021621	FIXED BEARING UNI COMPONENT	Biomet, Inc.	2002-06-05	20	0
K020741	UNICONDYLAR KNEE	Encore Orthopedics, Inc.	2002-06-04	90	2
K012800	SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM	Whiteside Biomechanics, Inc.	2002-05-03	255	0
K014171	ADVANCE UNICONDYLAR KNEE SYSTEM	Wrightmedicaltechnologyinc	2002-03-15	85	0
K020264	REPICCI II UNICONDYLAR KNEE SYSTEM	Biomet Orthopedics, Inc.	2002-02-08	14	0
K012762	MJS POSTERIOR STABILIZED KNEE SYSTEM	Osteoimplant Technology, Inc.	2001-12-11	116	0
K012591	ADVANCE UNICONDYLAR KNEE SYSTEM	Wrightmedicaltechnologyinc	2001-11-02	84	0
K011138	OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT	Biomet, Inc.	2001-07-10	88	1
K011795	WORLAND UNICONDYLAR TIBIAL BEARING	Biomet, Inc.	2001-06-13	5	0
K011509	BARRETT UNICONDYLAR TIBIAL BEARING	Biomet, Inc.	2001-06-13	28	0
K010810	DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS	DePuy Orthopaedics, Inc.	2001-04-18	30	19
K001451	MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHES	DePuy Orthopaedics, Inc.	2000-05-18	9	0
K983657	OSTEONICS SERIES 7000 AD TIBIAL TRAY	Osteonics Corp.	2000-04-06	535	0
K000172	DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS	DePuy Orthopaedics, Inc.	2000-02-03	14	0
K982859	UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM	Plus Orthopedics	1999-07-30	351	1
K980665	REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS	Biomet, Inc.	1998-05-20	89	1
K974434	OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS	Osteonics Corp.	1998-01-12	49	0
K971938	REPICCI II UNICONDYLAR KNEE	Biomet, Inc.	1997-08-25	90	1
K954481	P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM	Johnson & Johnson Professionals, Inc.	1996-10-10	379	0
K961900	TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL	Wrightmedicaltechnologyinc	1996-07-25	70	0
K960617	ADVANCE TIBIAL COMPONENT	Wrightmedicaltechnologyinc	1996-05-08	85	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