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 Wrightmedicaltechnologyinc.

91
Total
91
Cleared
106d
Avg days
1976
Since
91 devices
25–48 of 91
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 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
Cleared Jul 25, 1996
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
K961900
Wrightmedicaltechnologyinc
Orthopedic · 70d
Cleared May 08, 1996
ADVANCE TIBIAL COMPONENT
K960617
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 08, 1996
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
K955778
Intermedics Orthopedics
Orthopedic · 79d
Cleared Sep 26, 1995
GAS PLASMA STERILIZATION
K944538
Depuy, Inc.
Orthopedic · 376d