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

KWA — Predicate Candidate Screening

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

91 daysmedian FDA review time

237 days90th percentile

114clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K122778	PROFEMUR Z REVISION HIP STEM	Wrightmedicaltechnologyinc	2012-10-11	30	0
K121544	DYNASTY BIOFOAM SHELL	Wrightmedicaltechnologyinc	2012-07-30	66	0
K113271	METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS	Biomet Manufacturing, Inc.	2012-05-18	196	0
K113322	CONSERVE THIN SHELL	Wrightmedicaltechnologyinc	2012-02-03	85	0
K112080	PRESERVE HIP STEM	Wrightmedicaltechnologyinc	2011-12-28	160	0
K112150	PROFEMUR GLADIATOR HA HIP STEM	Wrightmedicaltechnologyinc	2011-11-23	119	0
K113019	PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CEN	Wrightmedicaltechnologyinc	2011-11-10	30	0
K111910	GLADIATOR HIP STEM	Wrightmedicaltechnologyinc	2011-10-14	101	0
K110836	CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY	Zimmer GmbH	2011-10-07	196	0
K110400	TAPERLOC COMPLETE MICROPLASTY STEM	Biomet Manufacturing Corp	2011-09-30	231	0
K111698	PROFEMUR(R) E CEMENTLESS HIP STEM	Wrightmedicaltechnologyinc	2011-08-19	63	3
K111699	PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM	Wrightmedicaltechnologyinc	2011-08-19	63	0
K110399	GLADIATOR PLASMA CLASSIC HIP STEM	Wrightmedicaltechnologyinc	2011-05-10	88	0
K110029	CONSERVE BIO FOAM SHELL	Wrightmedicaltechnologyinc	2011-04-19	104	0
K103755	TAPERLOC COMPLETE, SIZE 5 AND 6	Biomet Manufacturing Corp	2011-01-21	29	0
K102565	ANTERIOR APPROACH HIP SURGERY INSTRUMENTS	Wrightmedicaltechnologyinc	2010-12-22	106	0
K100469	ARCOS INTERLOCKING DISTAL STEMS	Biomet Manufacturing Corp	2010-12-07	292	0
K101086	TAPERLOC COMPLETE	Biomet, Inc.	2010-09-03	137	0
K101475	COMPRESS ANTI-ROTATION SPINDLES	Biomet Manufacturing Corp	2010-06-18	21	0
K093235	RINGLOC + HYBRID ACETABULAR SYSTEM	Biomet, Inc.	2010-04-30	197	29
K092331	DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-14	Encore Medical L.P.	2010-03-03	211	1
K091003	ZIMMER MMC CUP	Zimmer GmbH	2009-11-24	230	0
K091973	METASUL TAPER LINERS, METASUL FEMORAL HEADS	Zimmer GmbH	2009-11-17	139	2
K090757	BIOMET MODULAR FEMORAL REVISION SYSTEM	Biomet, Inc.	2009-09-25	186	0
K091423	PROFEMUR HIP SYSTEM MODULAR NECKS	Wrightmedicaltechnologyinc	2009-08-25	104	2
K083651	REVELATION STEM, MODEL 427-21/42-080/180	Encore Medical L.P.	2009-03-13	94	0
K082924	DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETAB	Wrightmedicaltechnologyinc	2009-03-06	156	17
K083642	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	DePuy Orthopaedics, Inc.	2009-03-06	87	0
K082585	DEPUY ASPHERE M-SPEC HEAD	DePuy Orthopaedics, Inc.	2008-12-04	87	0
K082446	BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATION	Biomet, Inc.	2008-10-15	51	1
K080991	DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM	DePuy Orthopaedics, Inc.	2008-07-02	86	41
K081090	PROFEMUR LX 5/8 COATED HIP STEM	Wrightmedicaltechnologyinc	2008-05-15	29	0
K081007	ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYS	Zimmer, Inc.	2008-05-06	28	0
K080663	PROFEMUR LX REVISION 5/8 COATED HIP STEM	Wrightmedicaltechnologyinc	2008-04-08	29	0
K073637	PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS	Biomet Manufacturing Corp	2008-03-20	85	0
K071723	ZIMMER POROLOCK MIS STEM	Zimmer GmbH	2008-03-07	256	1
K073413	DEPUY ASR 300 ACETABULAR CUP SYSTEM	DePuy Orthopaedics, Inc.	2008-01-30	57	36
K071856	ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYS	Zimmer, Inc.	2007-07-30	25	1
K070221	FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38	Encore Medical L.P.	2007-04-04	70	0
K070274	ECHO BI-METRIC PRESS-FIT STEMS	Biomet Manufacturing Corp	2007-04-03	64	1
K062994	LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS	Biomet Manufacturing Corp	2007-03-09	158	0
K070359	DEPUY ASR TAPER SLEEVE ADAPTER	DePuy Orthopaedics, Inc.	2007-03-06	27	2
K063614	ALTRA FX HIP SYSTEM	Biomet Manufacturing Corp	2007-02-20	77	0
K063251	ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY	Zimmer, Inc.	2007-01-24	89	1
K062998	COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE	Biomet Manufacturing Corp	2007-01-19	109	19
K062426	DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS	DePuy Orthopaedics, Inc.	2006-12-15	119	0
K063414	MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 4	Encore Medical L.P.	2006-12-12	29	0
K063002	ALTRA PRESS-FIT HIP SYSTEM	Biomet Manufacturing Corp	2006-10-31	29	0
K062995	M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT	Biomet Manufacturing Corp	2006-10-31	29	0
K061221	DUPUY S-ROM STD HIP STEM PROSTHESIS	DePuy Orthopaedics, Inc.	2006-08-28	118	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