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
49–72 of 108
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482
Depuy, Inc.
Orthopedic · 60d
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
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 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 19, 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025
Biomet, Inc.
Orthopedic · 113d
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 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