ClearanceBrief
Panels › Orthopedic › Product code KRO · Class 2

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Regulation 888.3510

2510(k)s in 12 months (87 all time)
28recalls in 12 months (124 all time)
121recalls that name a 510(k)
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Top companies in KRO

Decided510(k)Device and applicantCode
Aug 10, 2005K051479RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
Biomet Manufacturing, Inc.
KRO
Aug 5, 2005K051570AVL HINGE KNEE SYSTEM
Biomet, Inc.
KRO
Jul 30, 2004K041352COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
Biomet, Inc.
KRO
Jun 17, 2004K040749MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
Howmedica Osteonics Corp.
KRO
Dec 18, 2003K031804COMPRESS DISTAL FEMORAL REPLACEMENT
Biomet, Inc.
KRO
Jul 31, 2003K031480GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
Howmedica Osteonics Corp.
KRO
Dec 24, 2002K023667RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
Plus Orthopedics
KRO
Dec 16, 2002K023087GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
Howmedica Osteonics Corp.
KRO
Dec 4, 2002K021489REPIPHYSIS LIMB SALVAGE SYSTEM
Wrightmedicaltechnologyinc
KRO
Jun 21, 2002K021714RT-PLUS PE INSERT CLAMP
Plus Orthopedics
KRO
Jun 5, 2002K021260REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
Biomet, Inc.
KRO
May 6, 2002K020381EXPANDABLE KNEE
Biomet Orthopedics, Inc.
KRO
Jan 9, 2002K013385NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
Zimmer, Inc.
KRO
Dec 20, 2001K013340RT-PLUS KNEE ADDITIONAL COMPONENTS
Plus Orthopedics
KRO
Dec 7, 2001K013035GUARDIAN LIMB SALVAGE SYSTEM
Wrightmedicaltechnologyinc
KRO
Dec 7, 2001K013031MOST OPTIONS SYSTEM
Sulzer Orthopedics, Inc.
KRO
Sep 7, 2001K011810ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
Depuy, Inc.
KRO
May 11, 2001K003504RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
Plus Orthopedics
KRO
Apr 13, 2001K010774AVL HINGE KNEE SYSTEM
Biomet, Inc.
KRO
Nov 13, 2000K002552HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
Howmedica Osteonics Corp.
KRO
Jul 25, 2000K001957MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
Howmedica Osteonics Corp.
KRO
Jun 7, 2000K001548MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
Howmedica Osteonics Corp.
KRO
Mar 13, 2000K994207HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
Howmedica Osteonics Corp.
KRO
Mar 17, 1999K982160HINGED KNEE
Encore Orthopedics, Inc.
KRO
Jul 13, 1998K972401HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
Howmedica Corp.
KRO
Feb 14, 1996K945028FINN KNEE SYSTEM
Biomet, Inc.
KRO
Jul 26, 1991K910877FINN KNEE PROSTHESIS
Biomet, Inc.
KRO
May 29, 1991K910596DCW MODULAR DISTAL FEMORAL SYSTEM
Dow Corning Wright
KRO
Mar 14, 1990K896048S-ROM/NOILES MARK 3
Joint Medical Products Corp.
KRO
Feb 7, 1983K823420KINEMATIC II KNEE SYSTEM
Howmedica Corp.
KRO
Dec 3, 1982K823115NATURALYTE BICARBONATE DIALYSATE 4400
Erika, Inc.
KRO
Jun 23, 1982K821476BARD ENDO LINK INTRACONDYLAR ROTATING
C.R. Bard, Inc.
KRO
May 27, 1982K821340VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
Intermedics Orthopedics
KRO
May 25, 1982K820995MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
Ludek Optics, Inc.
KRO
Jul 27, 1981K811105SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
Allo Pro Corp.
KRO
Mar 26, 1981K810520INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
Zimmer, Inc.
KRO
Apr 4, 1979K781971KNEE SYSTEM, QUADRAXIAL CONSTRAINED
Hexcel Medical
KRO

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