KRO · Class II · 21 CFR 888.3510

FDA Product Code KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Constrained knee designs address the most challenging revision and deformity cases in orthopedic surgery. FDA product code KRO covers constrained cemented femorotibial knee prostheses.

These implants provide mechanical constraint of varus-valgus and rotational motion through a linked hinge or post-cam mechanism, compensating for severe ligamentous insufficiency that cannot be managed with less constrained designs.

KRO devices are Class II medical devices, regulated under 21 CFR 888.3510 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Howmedica Osteonics Corp., Biomet, Inc. and Zimmer, Inc..

86
Total
86
Cleared
121d
Avg days
1979
Since
86 devices
25–48 of 86
Cleared Aug 15, 2013
GMK HINGE
K130299
Medacta International
Orthopedic · 189d
Cleared Feb 22, 2013
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
K122015
Howmedica Osteonics Corp.
Orthopedic · 227d
Cleared Jul 01, 2011
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K110940
Zimmer, Inc.
Orthopedic · 88d
Cleared Aug 12, 2009
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K091453
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Apr 03, 2009
MAK OSS KNEE FEMORAL COMPONENTS
K083779
Biomet Manufacturing Corp
Orthopedic · 105d
Cleared Feb 13, 2009
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K083827
Biomet Manufacturing Corp
Orthopedic · 52d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jun 11, 2008
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
K080330
Biomet, Inc.
Orthopedic · 126d
Cleared Jan 09, 2008
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
K072367
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Jul 03, 2007
ZIMMER SEGMENTAL SYSTEM
K070978
Zimmer, Inc.
Orthopedic · 88d
Cleared Oct 13, 2006
DEPUY LPS PROXIMAL TIBIAL COMPONENT
K062301
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared Mar 15, 2006
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
K060360
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Feb 15, 2006
OSS-BODIES PROXIMAL TIBIAL SLEEVE
K060131
Biomet Manufacturing Corp
Orthopedic · 28d
Cleared Oct 27, 2005
ORTHOPEDIC SALVAGE SYSTEM- OSS
K052685
Biomet, Inc.
Orthopedic · 29d
Cleared Aug 05, 2005
AVL HINGE KNEE SYSTEM
K051570
Biomet, Inc.
Orthopedic · 52d
Cleared Jul 30, 2004
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352
Biomet, Inc.
Orthopedic · 71d
Cleared Jun 17, 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804
Biomet, Inc.
Orthopedic · 190d
Cleared Jul 31, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Dec 24, 2002
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667
Plus Orthopedics
Orthopedic · 54d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 04, 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Jun 21, 2002
RT-PLUS PE INSERT CLAMP
K021714
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 05, 2002
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K021260
Biomet, Inc.
Orthopedic · 47d