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
49–72 of 91
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 Jan 19, 1995
S.T.E.P. UNI-KNEE
K940389
S.T.E.P. Orthopaedics, Inc.
Orthopedic · 358d
Cleared Oct 11, 1994
CKS POROUS COATED FEMORAL COMPONENT
K933935
Techmedica, Inc.
Orthopedic · 426d
Cleared Nov 30, 1993
OSTEONICS UNIX UNICOMPARTMENTAL
K923011
Osteonics Corp.
Orthopedic · 526d
Cleared Aug 26, 1991
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 173d
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
Cleared Jun 27, 1986
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125
Depuy, Inc.
Orthopedic · 24d
Cleared Mar 10, 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133
Depuy, Inc.
Orthopedic · 55d
Cleared Aug 17, 1984
HOWMEDICA KINEMATIC II TIBIAL WEDGE
K842367
Howmedica Corp.
Orthopedic · 63d
Cleared Feb 13, 1984
UNICONDYLAR FIBER METAL KNEE
K834298
Zimmer, Inc.
Orthopedic · 67d
Cleared Aug 16, 1983
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143
Howmedica Corp.
Orthopedic · 131d
Cleared Jun 03, 1982
IOI METAL BACKED TIBIAL COMPONENT
K821341
Intermedics Orthopedics
Orthopedic · 29d
Cleared May 27, 1982
BARD CONTOUR LINK S.K.I. KNEE SYS
K820002
C.R. Bard, Inc.
Orthopedic · 143d
Cleared Feb 05, 1982
HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
K820030
Howmedica Corp.
Orthopedic · 31d