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 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 Aug 03, 1999
INTER-OP METASUL ACETABULAR SYSTEM
K974728
Sulzer Orthopedics, Inc.
Orthopedic · 593d
Cleared Jan 14, 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768
Osteonics Corp.
Orthopedic · 184d
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 Aug 09, 1985
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351
Kirschner Medical Corp.
Orthopedic · 70d
Cleared Jun 18, 1985
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404
Osteonics Corp.
Orthopedic · 70d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843940
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared May 01, 1985
ZIMMER THREADED ACETABULAR CUP
K850766
Zimmer, Inc.
Orthopedic · 65d
Cleared Apr 23, 1985
PROFILE FEMORAL HIP
K850055
Depuy, Inc.
Orthopedic · 105d
Cleared May 12, 1978
TOTAL HIP, LORD MADREPORIC
K780330
Howmedica Corp.
Orthopedic · 73d