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

KWZ — Predicate Candidate Screening

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

104 daysmedian FDA review time

207 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241461	Mpact Constrained Liner	Medacta International S.A.	2025-07-31	434	0
K240639	PINNACLETM Constrained Acetabular Liners	Depuy Ireland UC	2024-04-04	29	0
K162641	Smith & Nephew, Inc. R3™ Constrained Liner	Smith & Nephew, Inc.	2017-06-19	270	0
K163497	EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™	Encore Medical L.P.	2017-03-02	79	0
K161610	EXPRT Revision Hip System	Encore Medical L.P.	2016-11-09	152	0
K122139	SMITH & NEPHEW R3 CONSTRAINED LINERS	Smith & Nephew, Inc.	2012-10-16	89	0
K111635	SMITH & NEPHEW RJ CONSTRAINED LINERS	Smith & Nephew, Inc.	2011-09-09	88	0
K101730	LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LIN	Zimmer, Inc.	2010-12-03	168	0
K083566	R3 CONSTRAINED LINER, CONSTRAINED LINER	Smith & Nephew, Inc.	2009-03-03	90	13
K072121	TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAI	Zimmer, Inc.	2008-01-07	159	0
K071059	DEPUY SPA POROUS COATED PROXIMAL SLEEVE	DePuy Orthopaedics, Inc.	2007-11-09	207	0
K071676	EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS	Exactech, Inc.	2007-07-19	30	1
K071718	TRILOGY LONGEVITY CONSTRAINED LINER	Zimmer, Inc.	2007-07-13	21	1
K071117	MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS	DePuy Orthopaedics, Inc.	2007-05-18	28	1
K063552	SERIES II CONSTRAINED ACETABULAR LINERS	Howmedica Osteonics Corp.	2007-03-08	104	0
K063550	SYSTEM 12 CONSTRAINED ACETABULAR LINERS	Howmedica Osteonics Corp.	2007-03-08	104	0
K063445	PCA CONSTRAINED ACETABULAR LINERS	Howmedica Osteonics Corp.	2007-03-08	113	0
K061654	TRIDENT CONSTRAINED ACETABULAR INSERT	Howmedica Osteonics Corp.	2006-07-07	24	0
K052079	PINNACLE CONSTRAINED ACETABULAR LINERS	DePuy Orthopaedics, Inc.	2005-10-21	80	0
K043058	PINNACLE CONSTRAINED ACETABULAR LINERS	Depuy, Inc.	2005-03-14	129	0
K040601	EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINE	Exactech, Inc.	2004-10-04	210	0
K040225	OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM	Osteoimplant Technology, Inc.	2004-05-06	94	0
K033442	REFLECTION CONSTRAINED LINER	Smith & Nephew, Inc.	2003-11-26	28	0
K030923	EPSILON DURASUL CONSTRAINED ACETABULAR LINER	Centerpulse Orthopedics, Inc.	2003-10-03	193	0
K023794	CONSTRAINED LINER	Encore Medical L.P.	2003-04-01	139	0
K030047	FREEDOM CONSTRAINED LINERS	Biomet, Inc.	2003-01-23	17	0
K021826	TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERI	Zimmer, Inc.	2002-12-20	199	0
K021803	REFLECTION CONSTRAINED LINER	Smith & Nephew, Inc.	2002-12-19	199	0
K021728	RINGLOC CONSTRAINED LINERS II	Biomet, Inc.	2002-10-25	154	0
K021661	RINGLOC CONSTRAINED LINERS	Biomet Orthopedics, Inc.	2002-10-25	158	0
K950202	RINGLOC CONSTRAINED LINER	Biomet, Inc.	1995-05-15	117	0
K890197	OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT	Osteonics Corp.	1989-04-07	80	0
K870271	S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP	Joint Medical Products Corp.	1987-04-20	88	0
K803192	HCL ACETABULAR COMPONENTS	Osteonics Corp.	1981-01-23	38	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