KWL · Class II · 21 CFR 888.3360

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

Leading manufacturers include Osteonics Corp., Depuy, Inc. and Osteoremedies, LLC.

108
Total
108
Cleared
109d
Avg days
1979
Since
108 devices
49–72 of 108
Cleared Feb 12, 1993
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
K924379
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 165d
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 Dec 11, 1990
THOMPSON TYPE HIP PROSTHESIS
K905334
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
AUSTIN MOORE TYPE HIP PROTHESIS
K905349
O'Tec Corp.
Orthopedic · 13d
Cleared Oct 11, 1990
PROFILE COLLARED HIP PROSTHESIS
K904119
Depuy, Inc.
Orthopedic · 35d
Cleared Sep 13, 1990
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K903884
Kinamed, Inc.
Orthopedic · 23d
Cleared Sep 13, 1990
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K903885
Kinamed, Inc.
Orthopedic · 23d
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 Apr 30, 1990
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT
K900638
Johnson & Johnson International
Orthopedic · 80d
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
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482
Depuy, Inc.
Orthopedic · 60d
Cleared Feb 27, 1989
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
K884889
Protek, Inc.
Orthopedic · 97d
Cleared Feb 08, 1989
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K884789
Protek, Inc.
Orthopedic · 85d
Cleared Sep 22, 1988
HIP FRACTURE STEM SYSTEM
K883179
Howmedica Corp.
Orthopedic · 57d
Cleared Feb 03, 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915
Orthomet, Inc.
Orthopedic · 62d
Cleared Aug 26, 1987
BIOPRO FEMORAL HIP COMPONENT
K872535
Biopro, Inc.
Orthopedic · 61d