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 Aug 24, 1987
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K872776
Depuy, Inc.
Orthopedic · 41d
Cleared Aug 18, 1987
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K872025
Depuy, Inc.
Orthopedic · 84d
Cleared Aug 07, 1987
TRI-LOCK MODIFIED FEMORAL PROSTHESIS
K872878
Depuy, Inc.
Orthopedic · 17d
Cleared Jun 09, 1987
ORTHOMET AUSTIN-MOORE SYSTEM
K871656
Orthomet, Inc.
Orthopedic · 42d
Cleared Jan 28, 1987
BROOKER BIO-GROOVE FEMORAL COMPONENT
K864085
Biomet, Inc.
Orthopedic · 100d
Cleared Feb 27, 1986
BIO-FIT HIP SYSTEM
K854791
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Feb 11, 1986
FEMORAL HEMI-HIP PROSTHESES
K855228
Orthopaedic Device Corp.
Orthopedic · 43d
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 May 28, 1985
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
K850928
Unitas Ent.
Orthopedic · 84d
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 Mar 12, 1985
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K844488
Mecron Medical Products, Inc.
Orthopedic · 113d
Cleared Feb 19, 1985
MECRON MRC-HEADLESS FEMORAL COMPONENT
K844486
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Feb 19, 1985
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
K844487
Mecron Medical Products, Inc.
Orthopedic · 92d
Cleared Dec 20, 1984
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 171d
Cleared Nov 19, 1984
UNILOC
K842465
American Ortomed Corp.
Orthopedic · 147d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL STEM
K842234
Endomedics, Inc.
Orthopedic · 45d
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 Oct 06, 1983
STRAIGHT STEM FEMORAL HEAD PROSTHESIS
K831851
Proteck, Inc.
Orthopedic · 119d