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Panels › Orthopedic › Product code HSX · Class 2

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

Regulation 888.3520

3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
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Top companies in HSX

Company510(k)sRecalls
Smith & Nephew, Inc.1354
Linkbio Corp.032
Conformis, Inc.83
Zimmer, Inc.92
Bodycad Laboratories, Inc.70
Mako Surgical Corp.60
Zimmer Biomet15
Depuy, Inc.50
Howmedica Corp.50
Medacta International S.A.50
Decided510(k)Device and applicantCode
Aug 4, 1987K872735HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
Howmedica Corp.
HSX
Mar 25, 1987K862632INSALL/BURSTEIN(TM)* II TIBIAL WEDGES
Zimmer, Inc.
HSX
Dec 22, 1986K862837OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
Osteonics Corp.
HSX
Jul 14, 1986K862136MODIFIED WHITESIDE POSTERIOR STABILIZED TOTAL KNEE
Dow Corning Wright
HSX
Jul 14, 1986K861715WHITESIDE CONDYLAR II TOTAL KNEE PROSTHESIS
Dow Corning Wright
HSX
Dec 9, 1985K854325TRICON UNICOMPARTMENTAL KNEE SYSTEM
Richards Medical Co., Inc.
HSX
Nov 25, 1985K853020POROCOAT SYNATOMIC UNICONDYLAR KNEE
Depuy, Inc.
HSX
Sep 4, 1985K853268FREEMAN UNI-COMPARTMENTAL KNEE
Protek, Inc.
HSX
Feb 19, 1985K844706TRICON REVISION TOTAL KNEE SYSTEM
Richards Medical Co., Inc.
HSX
Feb 7, 1985K844355SYNATOMIC STANDARD TIBIAL PLATEAU
Depuy, Inc.
HSX
Jul 28, 1983K831513KENNEDY TIBIAL COMPONENT
Biomet, Inc.
HSX
Feb 4, 1981K803235GEO-TIBIAL RETAINER ROTATIONAL
Zimmer, Inc.
HSX
Apr 21, 1980K800640MEDICAL COMPARTMENT KNEE PROSTHESIS
Dow Corning Wright
HSX
Dec 5, 1979K792240POLYCENTRIC TOTAL KNEE METAL TIBIAL
Howmedica Corp.
HSX
Nov 30, 1977K771511TOTAL KNEE PROSTHESIS-NONCONSTRAINED
3M Company
HSX

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