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

FDA product code KWZ · 34 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3310
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1981-01-23 – 2025-07-31

KWZ 2025-07-31

Mpact Constrained Liner

Applicant Medacta International S.A.

K number K241461

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KWZ 2024-04-04

PINNACLETM Constrained Acetabular Liners

Applicant Depuy Ireland UC

K number K240639

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KWZ 2017-06-19

Smith & Nephew, Inc. R3™ Constrained Liner

Applicant Smith & Nephew, Inc.

K number K162641

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KWZ 2017-03-02

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

Applicant Encore Medical L.P.

K number K163497

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KWZ 2016-11-09

EXPRT Revision Hip System

Applicant Encore Medical L.P.

K number K161610

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KWZ 2012-10-16

SMITH & NEPHEW R3 CONSTRAINED LINERS

Applicant Smith & Nephew, Inc.

K number K122139

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KWZ 2011-09-09

SMITH & NEPHEW RJ CONSTRAINED LINERS

Applicant Smith & Nephew, Inc.

K number K111635

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KWZ 2010-12-03

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS

Applicant Zimmer, Inc.

K number K101730

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KWZ 2009-03-03

R3 CONSTRAINED LINER, CONSTRAINED LINER

Applicant Smith & Nephew, Inc.

K number K083566

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KWZ 2008-01-07

TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER

Applicant Zimmer, Inc.

K number K072121

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KWZ 2007-11-09

DEPUY SPA POROUS COATED PROXIMAL SLEEVE

Applicant DePuy Orthopaedics, Inc.

K number K071059

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KWZ 2007-07-19

EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS

Applicant Exactech, Inc.

K number K071676

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KWZ 2007-07-13

TRILOGY LONGEVITY CONSTRAINED LINER

Applicant Zimmer, Inc.

K number K071718

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KWZ 2007-05-18

MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS

Applicant DePuy Orthopaedics, Inc.

K number K071117

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KWZ 2007-03-08

SERIES II CONSTRAINED ACETABULAR LINERS

Applicant Howmedica Osteonics Corp.

K number K063552

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KWZ 2007-03-08

SYSTEM 12 CONSTRAINED ACETABULAR LINERS

Applicant Howmedica Osteonics Corp.

K number K063550

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KWZ 2007-03-08

PCA CONSTRAINED ACETABULAR LINERS

Applicant Howmedica Osteonics Corp.

K number K063445

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KWZ 2006-07-07

TRIDENT CONSTRAINED ACETABULAR INSERT

Applicant Howmedica Osteonics Corp.

K number K061654

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KWZ 2005-10-21

PINNACLE CONSTRAINED ACETABULAR LINERS

Applicant DePuy Orthopaedics, Inc.

K number K052079

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KWZ 2005-03-14

PINNACLE CONSTRAINED ACETABULAR LINERS

Applicant Depuy, Inc.

K number K043058

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KWZ 2004-10-04

EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS

Applicant Exactech, Inc.

K number K040601

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KWZ 2004-05-06

OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

Applicant Osteoimplant Technology, Inc.

K number K040225

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KWZ 2003-11-26

REFLECTION CONSTRAINED LINER

Applicant Smith & Nephew, Inc.

K number K033442

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KWZ 2003-10-03

EPSILON DURASUL CONSTRAINED ACETABULAR LINER

Applicant Centerpulse Orthopedics, Inc.

K number K030923

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KWZ 2003-04-01

CONSTRAINED LINER

Applicant Encore Medical L.P.

K number K023794

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KWZ 2003-01-23

FREEDOM CONSTRAINED LINERS

Applicant Biomet, Inc.

K number K030047

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KWZ 2002-12-20

TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES

Applicant Zimmer, Inc.

K number K021826

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KWZ 2002-12-19

REFLECTION CONSTRAINED LINER

Applicant Smith & Nephew, Inc.

K number K021803

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KWZ 2002-10-25

RINGLOC CONSTRAINED LINERS II

Applicant Biomet, Inc.

K number K021728

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KWZ 2002-10-25

RINGLOC CONSTRAINED LINERS

Applicant Biomet Orthopedics, Inc.

K number K021661

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KWZ 1995-05-15

RINGLOC CONSTRAINED LINER

Applicant Biomet, Inc.

K number K950202

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KWZ 1989-04-07

OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT

Applicant Osteonics Corp.

K number K890197

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KWZ 1987-04-20

S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP

Applicant Joint Medical Products Corp.

K number K870271

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KWZ 1981-01-23

HCL ACETABULAR COMPONENTS

Applicant Osteonics Corp.

K number K803192

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