HRY · Class II · 21 CFR 888.3530

FDA Product Code HRY: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

Leading manufacturers include Howmedica Corp., Biomet, Inc. and Depuy, Inc..

91
Total
91
Cleared
106d
Avg days
1976
Since
91 devices
25–48 of 91
Cleared Mar 05, 2004
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
K033810
Centerpulse Orthopedics, Inc.
Orthopedic · 88d
Cleared Jul 25, 2003
UC-PLUS SOLUTION UNICONDYLAR KNEE
K032052
Plus Orthopedics
Orthopedic · 23d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446
Biomet, Inc.
Orthopedic · 23d
Cleared Feb 20, 2003
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Aug 23, 2002
UNI KNEE
K022437
Encore Medical, L.P.
Orthopedic · 29d
Cleared Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621
Biomet, Inc.
Orthopedic · 20d
Cleared Jun 04, 2002
UNICONDYLAR KNEE
K020741
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared May 03, 2002
SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
K012800
Whiteside Biomechanics, Inc.
Orthopedic · 255d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 08, 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762
Osteoimplant Technology, Inc.
Orthopedic · 116d
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138
Biomet, Inc.
Orthopedic · 88d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509
Biomet, Inc.
Orthopedic · 28d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795
Biomet, Inc.
Orthopedic · 5d
Cleared Apr 18, 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared May 18, 2000
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K001451
DePuy Orthopaedics, Inc.
Orthopedic · 9d
Cleared Apr 06, 2000
OSTEONICS SERIES 7000 AD TIBIAL TRAY
K983657
Osteonics Corp.
Orthopedic · 535d
Cleared Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared Jul 30, 1999
UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
K982859
Plus Orthopedics
Orthopedic · 351d
Cleared May 20, 1998
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665
Biomet, Inc.
Orthopedic · 89d
Cleared Jan 12, 1998
OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
K974434
Osteonics Corp.
Orthopedic · 49d
Cleared Aug 25, 1997
REPICCI II UNICONDYLAR KNEE
K971938
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 10, 1996
P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
K954481
Johnson & Johnson Professionals, Inc.
Orthopedic · 379d