KWL · Class II · 21 CFR 888.3360

FDA Product Code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Leading manufacturers include Osteonics Corp., Depuy, Inc. and Biomet, Inc..

108
Total
108
Cleared
109d
Avg days
1979
Since
108 devices
73–96 of 108
Cleared Sep 24, 1985
MUELLER CURVED STEM HEMI-PROSTHESIS
K853662
Protek, Inc.
Orthopedic · 21d
Cleared Aug 15, 1985
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584
Biomet, Inc.
Orthopedic · 58d
Cleared Jul 30, 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818
Osteonics Corp.
Orthopedic · 231d
Cleared Jun 28, 1985
BTM TOTAL HIP SYSTEM
K852420
Kirschner Medical Corp.
Orthopedic · 21d
Cleared Apr 23, 1985
TF-II HIP PROSTHESIS
K843995
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 194d
Cleared Apr 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025
Biomet, Inc.
Orthopedic · 113d
Cleared Dec 20, 1984
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 171d
Cleared Jun 25, 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437
Biomet, Inc.
Orthopedic · 80d
Cleared Mar 19, 1984
MODIFIED HPS HIP PROSTHESIS
K833599
Depuy, Inc.
Orthopedic · 159d
Cleared Jan 10, 1984
BDH UNIPOLAR FEMORAL COMPONENT A2
K833403
Carbomedics, Inc.
Orthopedic · 102d
Cleared Mar 10, 1983
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307
Howmedica Corp.
Orthopedic · 38d
Cleared Dec 03, 1982
METAL KNEE & HIP PROSTHESIS
K823051
Zimmer, Inc.
Orthopedic · 46d
Cleared Aug 20, 1982
IOI 32 TM FEMORAL COMPONENT
K822321
Intermedics Orthopedics
Orthopedic · 17d
Cleared Aug 19, 1982
KAMPNER FEMORAL COMPONENT
K822320
Intermedics Orthopedics
Orthopedic · 16d
Cleared Jun 03, 1982
BDH FEMORAL COMPONENT
K821343
Intermedics Orthopedics
Orthopedic · 29d
Cleared Aug 12, 1981
MOORE HIP PROSTHESIS, PMMA COATED
K811416
Zimmer, Inc.
Orthopedic · 85d
Cleared Jul 20, 1981
COLLARLESS TAPERED STEM HIP PROSTH. DEV
K811738
Biomet, Inc.
Orthopedic · 31d
Cleared Jan 23, 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191
Osteonics Corp.
Orthopedic · 38d
Cleared Feb 11, 1980
UHR UNIVERSAL6HIP REPLACEMENT
K800207
Osteonics Corp.
Orthopedic · 12d
Cleared Nov 15, 1979
3M HS 22 FEMORAL COMPONENT
K792181
3M Company
Orthopedic · 17d