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

FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer Devices (Product Code HRY)

91 devices
1–24 of 91
Cleared Apr 16, 2020
SIGMA High Performance (HP) Partial Knee System
K193549
Depuy Ireland UC
Orthopedic · 118d
Cleared Dec 20, 2019
NanoOrtho NanoKnee® System
K190633
Nanoortho, LLC
Orthopedic · 283d
Cleared Aug 10, 2010
EVOLUTION UNICONDYLAR KNEE SYSTEM
K100973
Wrightmedicaltechnologyinc
Orthopedic · 124d
Cleared Oct 03, 2008
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 09, 2007
TRIATHLON PKR SYSTEM
K071881
Howmedica Osteonics Corp.
Orthopedic · 92d
Cleared Aug 17, 2007
DEPUY GCK TIBIAL COMPONENTS
K070267
DePuy Orthopaedics, Inc.
Orthopedic · 200d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093
Biomet, Inc.
Orthopedic · 90d
Cleared May 05, 2004
DEPUY PRESERVATION UNICONDYLAR TIBIA
K040268
DePuy Orthopaedics, Inc.
Orthopedic · 90d
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 Jun 05, 2002
FIXED BEARING UNI COMPONENT
K021621
Biomet, Inc.
Orthopedic · 20d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171
Wrightmedicaltechnologyinc
Orthopedic · 85d
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 Feb 03, 2000
DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K000172
DePuy Orthopaedics, Inc.
Orthopedic · 14d
Cleared May 20, 1998
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665
Biomet, Inc.
Orthopedic · 89d
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

About Product Code HRY - Regulatory Context