KWA · Class III · 21 CFR 888.3330

FDA Product Code KWA: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

Leading manufacturers include Wrightmedicaltechnologyinc, Biomet Manufacturing Corp and DePuy Orthopaedics, Inc..

114
Total
114
Cleared
119d
Avg days
1978
Since
114 devices
73–96 of 114
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250
Encore Orthopedics, Inc.
Orthopedic · 100d
Cleared Dec 13, 2000
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 13, 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Aug 31, 2000
M2A 28MM RINGLOC LINER
K002379
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 10, 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Jul 27, 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536
Sulzer Orthopedics, Inc.
Orthopedic · 71d
Cleared May 18, 2000
METAL ON METAL ACETABULAR SYSTEM
K993438
Biomet, Inc.
Orthopedic · 219d
Cleared Dec 01, 1999
APR METASUL ACETABULAR INSERT
K993569
Sulzermedica
Orthopedic · 41d
Cleared Aug 03, 1999
INTER-OP METASUL ACETABULAR SYSTEM
K974728
Sulzer Orthopedics, Inc.
Orthopedic · 593d
Cleared Feb 12, 1993
THOMPSON TYPE HIP PROTHESIS
K922868
Osteo Technology, Inc.
Orthopedic · 253d
Cleared Aug 22, 1990
MODIFIED FREEMAN ACETABULAR CUP
K902110
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Aug 22, 1990
MODIFIED FREEMAN REVISION ACETABULAR CUP
K902111
Turnkey Intergration USA, Inc.
Orthopedic · 105d
Cleared Oct 20, 1988
SAMUELSON SCREWLOC CUP
K882671
Protek, Inc.
Orthopedic · 114d
Cleared Aug 19, 1988
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675
Kinamed, Inc.
Orthopedic · 52d
Cleared Jan 14, 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768
Osteonics Corp.
Orthopedic · 184d
Cleared Oct 01, 1987
SAMUELSON ACETABULAR CUP
K872985
Protek, Inc.
Orthopedic · 62d
Cleared Sep 14, 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923
Protek, Inc.
Orthopedic · 194d
Cleared Sep 14, 1987
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
K870924
Protek, Inc.
Orthopedic · 194d
Cleared Jun 23, 1987
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956
Downs Surgical , Ltd.
Orthopedic · 34d
Cleared Mar 13, 1987
RING UPM TOTAL HIP REPLACEMENT
K864515
Downs Surgical , Ltd.
Orthopedic · 116d
Cleared Jun 09, 1986
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723
Osteonics Corp.
Orthopedic · 34d
Cleared Sep 05, 1985
FREEMAN ACETABULAR CUP
K852699
Advanced Biosearch Assn.
Orthopedic · 71d
Cleared Aug 09, 1985
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351
Kirschner Medical Corp.
Orthopedic · 70d
Cleared Jul 15, 1985
HOWMEDICA THREADED ACETABULAR COMPONENT
K850840
Pfizer, Inc.
Orthopedic · 136d