KWZ · Class II · 21 CFR 888.3310

FDA Product Code KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

Leading manufacturers include Smith & Nephew, Inc., Zimmer, Inc. and Howmedica Osteonics Corp..

34
Total
34
Cleared
121d
Avg days
1981
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 434d recently vs 111d historically

FDA 510(k) Cleared Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer Devices (Product Code KWZ)

34 devices
1–24 of 34
Cleared Jul 31, 2025
Mpact Constrained Liner
K241461
Medacta International S.A.
Orthopedic · 434d
Cleared Apr 04, 2024
PINNACLETM Constrained Acetabular Liners
K240639
Depuy Ireland UC
Orthopedic · 29d
Cleared Jun 19, 2017
Smith & Nephew, Inc. R3™ Constrained Liner
K162641
Smith & Nephew, Inc.
Orthopedic · 270d
Cleared Mar 02, 2017
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
K163497
Encore Medical, L.P.
Orthopedic · 79d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Sep 09, 2011
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
K101730
Zimmer, Inc.
Orthopedic · 168d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 07, 2008
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
K072121
Zimmer, Inc.
Orthopedic · 159d
Cleared Jul 13, 2007
TRILOGY LONGEVITY CONSTRAINED LINER
K071718
Zimmer, Inc.
Orthopedic · 21d
Cleared Mar 08, 2007
PCA CONSTRAINED ACETABULAR LINERS
K063445
Howmedica Osteonics Corp.
Orthopedic · 113d
Cleared Mar 08, 2007
SYSTEM 12 CONSTRAINED ACETABULAR LINERS
K063550
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Mar 08, 2007
SERIES II CONSTRAINED ACETABULAR LINERS
K063552
Howmedica Osteonics Corp.
Orthopedic · 104d
Cleared Jul 07, 2006
TRIDENT CONSTRAINED ACETABULAR INSERT
K061654
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Mar 14, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K043058
Depuy, Inc.
Orthopedic · 129d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047
Biomet, Inc.
Orthopedic · 17d
Cleared Dec 20, 2002
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826
Zimmer, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS II
K021728
Biomet, Inc.
Orthopedic · 154d
Cleared May 15, 1995
RINGLOC CONSTRAINED LINER
K950202
Biomet, Inc.
Orthopedic · 117d

About Product Code KWZ - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code KWZ since 1981, with 34 receiving FDA clearance (average review time: 121 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KWZ Product Code

Recent submissions under KWZ have taken an average of 434 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.

KWZ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →