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 Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Sep 01, 1999
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Mar 15, 1999
PLUS FRACTURE HEAD PROSTHESIS
K990309
Plus Orthopedics
Orthopedic · 42d
Cleared Feb 24, 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585
Osteonics Corp.
Orthopedic · 62d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028
Biomet, Inc.
Orthopedic · 68d
Cleared Aug 21, 1998
ARGOMEDICAL BIPOLAR SYSTEM
K981451
Stelkast Company
Orthopedic · 121d
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 Jul 23, 1997
ULTIMA TPS CEMENTED STEM
K965198
Johnson & Johnson International
Orthopedic · 209d
Cleared Jan 24, 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156
Johnson & Johnson Professionals, Inc.
Orthopedic · 32d
Cleared Sep 23, 1996
PRIME MODULAR ENDO HEAD
K962646
Orthopaedic Innovations, Inc.
Orthopedic · 77d
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 May 25, 1995
LINK SADDLE PROTHESIS
K951355
Turnkey Intergration USA, Inc.
Orthopedic · 78d
Cleared Oct 07, 1994
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
K931752
Corin Orthopedic Products
Orthopedic · 547d
Cleared Oct 07, 1994
CORIN THOMPSON PROSTHESIS, MODIFICATION
K931753
Corin Orthopedic Products
Orthopedic · 547d
Cleared Sep 29, 1994
ULTIMA UNIPOLAR MODULAR HEAD
K940190
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 259d
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