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
25–48 of 108
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 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
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