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
25–48 of 108
Cleared Mar 16, 1998
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807
Osteonics Corp.
Orthopedic · 83d
Cleared Dec 18, 1997
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Jan 24, 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156
Johnson & Johnson Professionals, Inc.
Orthopedic · 32d
Cleared Mar 27, 1996
OPTEON UNIPOLAR
K960538
Exactech, Inc.
Orthopedic · 49d
Cleared Jan 30, 1996
JOHNSON & JOHNSON AUSTIN MOORE STEM
K955385
Johnson & Johnson Professionals, Inc.
Orthopedic · 67d
Cleared Nov 30, 1995
OSTEONICS UNIPOLAR ENDO HEAD
K954534
Osteonics Corp.
Orthopedic · 62d
Cleared Nov 15, 1995
UNITRAX V40 MODULAR ADAPTOR
K954077
Howmedica Corp.
Orthopedic · 77d
Cleared Aug 14, 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778
Osteonics Corp.
Orthopedic · 377d
Cleared Jun 07, 1995
ULTIMA AUGMENTED UHMWPE CUP
K950563
Johnson & Johnson Professionals, Inc.
Orthopedic · 119d
Cleared Apr 25, 1994
ZIRCONIUM ALLOY UNI-POLAR HEAD
K934353
Smith & Nephew Richards, Inc.
Orthopedic · 229d
Cleared Aug 25, 1993
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
K924050
Orthomet, Inc.
Orthopedic · 385d
Cleared Mar 31, 1993
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K926120
Depuy, Inc.
Orthopedic · 118d
Cleared Aug 11, 1992
OSTRONCS HEMI-HIP STEM SERIES
K922146
Osteonics Corp.
Orthopedic · 96d
Cleared Jun 08, 1992
OMNIFLEX M-HA HIP STEM SERIES
K920193
Stryker Corp.
Orthopedic · 145d
Cleared Jun 08, 1992
OMNIFIT M-HA HIP STEM SERIES
K920231
Stryker Corp.
Orthopedic · 143d
Cleared Mar 23, 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868
Orthomet, Inc.
Orthopedic · 84d
Cleared Jan 18, 1991
MTS FEMORAL HIP SYSTEM
K903877
3M Company
Orthopedic · 149d
Cleared Jan 11, 1991
MODULAR UNIPOLAR SYSTEM
K902365
Howmedica Corp.
Orthopedic · 226d
Cleared Oct 11, 1990
PROFILE COLLARED HIP PROSTHESIS
K904119
Depuy, Inc.
Orthopedic · 35d
Cleared Jul 30, 1990
THOMPSON TYPE HIS PROSTHESIS
K903240
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
AUSTIN MOORE TYPE HIP PROSTHESIS
K903241
Onyx Medical Corp.
Orthopedic · 6d
Cleared May 02, 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853
Howmedica Corp.
Orthopedic · 148d
Cleared Dec 29, 1989
EVOLUTION HIP SYSTEM
K896105
Dow Corning Wright
Orthopedic · 70d
Cleared Dec 01, 1989
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
K895886
Biopro, Inc.
Orthopedic · 57d