Product Code: KWZ FDA class 2 21 CFR 888.3310

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Orthopedic

The Constrained Metal/Polymer Cemented or Uncemented Hip Prosthesis is an orthopedic total hip implant with a fully constrained design using metal and polymer components, accommodating either cemented or cementless fixation, indicated for patients with severe hip joint disease requiring maximum mechanical stability. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWZ, regulated under 21 CFR 888.3310, in the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

156

Registration Numbers

156

Unique Applicants

Years Active

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Basic Information

Product Code: KWZ
Device Class: FDA class 2
Regulation Number: 888.3310
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241461	Mpact Constrained Liner	Jul 31, 2025	Substantially Equivalent	Medacta International S.A.
K240639	PINNACLETM Constrained Acetabular Liners	Apr 04, 2024	Substantially Equivalent	Depuy Ireland UC
K162641	Smith & Nephew, Inc. R3 Constrained Liner	Jun 19, 2017	Substantially Equivalent	Smith & Nephew, Inc.
K163497	EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt	Mar 02, 2017	Substantially Equivalent	Encore Medical L.P.
K161610	EXPRT Revision Hip System	Nov 09, 2016	Substantially Equivalent	Encore Medical L.P.
K122139	SMITH & NEPHEW R3 CONSTRAINED LINERS	Oct 16, 2012	Substantially Equivalent	Smith & Nephew, Inc.
K111635	SMITH & NEPHEW RJ CONSTRAINED LINERS	Sep 09, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K101730	LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS	Dec 03, 2010	Substantially Equivalent	Zimmer, Inc.
K083566	R3 CONSTRAINED LINER, CONSTRAINED LINER	Mar 03, 2009	Substantially Equivalent	Smith & Nephew, Inc.
K072121	TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER	Jan 07, 2008	Substantially Equivalent	Zimmer, Inc.
K071059	DEPUY SPA POROUS COATED PROXIMAL SLEEVE	Nov 09, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K071676	EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS	Jul 19, 2007	Substantially Equivalent	Exactech, Inc.
K071718	TRILOGY LONGEVITY CONSTRAINED LINER	Jul 13, 2007	Substantially Equivalent	Zimmer, Inc.
K071117	MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS	May 18, 2007	Substantially Equivalent	DePuy Orthopaedics, Inc.
K063552	SERIES II CONSTRAINED ACETABULAR LINERS	Mar 08, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K063550	SYSTEM 12 CONSTRAINED ACETABULAR LINERS	Mar 08, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K063445	PCA CONSTRAINED ACETABULAR LINERS	Mar 08, 2007	Substantially Equivalent	Howmedica Osteonics Corp.
K061654	TRIDENT CONSTRAINED ACETABULAR INSERT	Jul 07, 2006	Substantially Equivalent	Howmedica Osteonics Corp.
K052079	PINNACLE CONSTRAINED ACETABULAR LINERS	Oct 21, 2005	Substantially Equivalent	DePuy Orthopaedics, Inc.
K043058	PINNACLE CONSTRAINED ACETABULAR LINERS	Mar 14, 2005	Substantially Equivalent	Depuy, Inc.
K040601	EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS	Oct 04, 2004	Substantially Equivalent	Exactech, Inc.
K040225	OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM	May 06, 2004	Substantially Equivalent	Osteoimplant Technology, Inc.
K033442	REFLECTION CONSTRAINED LINER	Nov 26, 2003	Substantially Equivalent	Smith & Nephew, Inc.
K030923	EPSILON DURASUL CONSTRAINED ACETABULAR LINER	Oct 03, 2003	Substantially Equivalent	Centerpulse Orthopedics, Inc.
K023794	CONSTRAINED LINER	Apr 01, 2003	Substantially Equivalent	Encore Medical L.P.
K030047	FREEDOM CONSTRAINED LINERS	Jan 23, 2003	Substantially Equivalent	Biomet, Inc.
K021826	TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES	Dec 20, 2002	Substantially Equivalent	Zimmer, Inc.
K021803	REFLECTION CONSTRAINED LINER	Dec 19, 2002	Substantially Equivalent	Smith & Nephew, Inc.
K021728	RINGLOC CONSTRAINED LINERS II	Oct 25, 2002	Substantially Equivalent	Biomet, Inc.
K021661	RINGLOC CONSTRAINED LINERS	Oct 25, 2002	Substantially Equivalent	Biomet Orthopedics, Inc.
K950202	RINGLOC CONSTRAINED LINER	May 15, 1995	Substantially Equivalent	Biomet, Inc.
K890197	OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT	Apr 07, 1989	Substantially Equivalent	Osteonics Corp.
K870271	S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP	Apr 20, 1987	Substantially Equivalent for Some Indications	Joint Medical Products Corp.
K803192	HCL ACETABULAR COMPONENTS	Jan 23, 1981	Substantially Equivalent	Osteonics Corp.