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..

87
Total
87
Cleared
120d
Avg days
1979
Since
87 devices
49–72 of 87
Cleared Aug 10, 2005
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
K051479
Biomet Manufacturing, Inc.
Orthopedic · 68d
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
Cleared May 06, 2002
EXPANDABLE KNEE
K020381
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 09, 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385
Zimmer, Inc.
Orthopedic · 89d
Cleared Dec 20, 2001
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340
Plus Orthopedics
Orthopedic · 72d
Cleared Dec 07, 2001
MOST OPTIONS SYSTEM
K013031
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 07, 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Sep 07, 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810
Depuy, Inc.
Orthopedic · 88d
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504
Plus Orthopedics
Orthopedic · 179d
Cleared Apr 13, 2001
AVL HINGE KNEE SYSTEM
K010774
Biomet, Inc.
Orthopedic · 30d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jun 07, 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 17, 1999
HINGED KNEE
K982160
Encore Orthopedics, Inc.
Orthopedic · 271d