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 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
Cleared Nov 30, 1993
OSTEONICS UNIX UNICOMPARTMENTAL
K923011
Osteonics Corp.
Orthopedic · 526d
Cleared Jun 26, 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373
Osteonics Corp.
Orthopedic · 90d
Cleared Jul 06, 1990
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538
Dow Corning Wright
Orthopedic · 30d
Cleared Nov 06, 1989
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044
Biopro, Inc.
Orthopedic · 305d
Cleared Apr 19, 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969
Intermedics Orthopedics
Orthopedic · 211d
Cleared Feb 17, 1989
KINEMAX TIBIAL WEDGE
K884837
Howmedica Corp.
Orthopedic · 91d
Cleared Jun 29, 1988
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241
Kirschner Medical Corp.
Orthopedic · 33d
Cleared Jan 20, 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601
Biomet, Inc.
Orthopedic · 149d
Cleared Jan 27, 1987
WHITESIDE ORTHOLOC (TM)
K864070
Dow Corning Wright
Orthopedic · 99d