FDA.report

Knee tibia prosthesis trial

Definition
A copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.
GUDID devices
12,334
Last updated
2022-03-18 08:46:36

Related Product Codes

CodeDeviceSpecialtyClassDevices
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic24,717
LXHOrthopedic Manual Surgical InstrumentOrthopedic12,695
HWTTemplateOrthopedic12,225
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2763
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2721
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2582
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2394
MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/PolymerOrthopedic292
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic282
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile BearingUnknown378
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic268
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic246
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery121
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic220
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery116
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology212
HRSPlate, Fixation, BoneOrthopedic211
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic210
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic28
HTWBit, DrillOrthopedic12
GIIGlutathione, Red-CellHematology21
HTJGauge, DepthOrthopedic11
HTQBroachOrthopedic11
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic21
OOGKnee Arthroplasty Implantation SystemOrthopedic21
QPPImplantable Post-Surgical Kinematic Measurement Knee DeviceOrthopedic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03596010222824PROFIXSmith & Nephew, Inc.715104112015-08-30
03596010222831PROFIXSmith & Nephew, Inc.715104122015-08-30
03596010222848PROFIXSmith & Nephew, Inc.715104312015-08-30
03596010222855PROFIXSmith & Nephew, Inc.715104322015-08-30
03596010222862PROFIXSmith & Nephew, Inc.715104512015-08-30
03596010222879PROFIXSmith & Nephew, Inc.715104522015-08-30
00885556079836GENESIS IISmith & Nephew, Inc.714309122022-03-01
00885556079881GENESIS IISmith & Nephew, Inc.714309132022-03-01
00885556080085GENESIS IISmith & Nephew, Inc.714309212022-03-01
00885556080184GENESIS IISmith & Nephew, Inc.714309232022-03-01
00885556080283GENESIS IISmith & Nephew, Inc.714309252022-03-01
00885556080337GENESIS IISmith & Nephew, Inc.714309262022-03-01
08033390205993PHYSICA HPSLIMACORPORATE SPA9065.39.1102022-02-12
08033390206631PHYSICA PS PROLIMACORPORATE SPA9065.38.A102022-02-12
08033390206648PHYSICA PS PROLIMACORPORATE SPA9065.38.A112022-02-12
08033390206655PHYSICA PS PROLIMACORPORATE SPA9065.38.A122022-02-12
08033390206662PHYSICA PS PROLIMACORPORATE SPA9065.38.A142022-02-12
08033390206679PHYSICA PS PROLIMACORPORATE SPA9065.38.A162022-02-12
08033390206686PHYSICA PS PROLIMACORPORATE SPA9065.38.A202022-02-12
08033390206693PHYSICA HPSLIMACORPORATE SPA9065.39.1112022-02-12
08033390206709PHYSICA HPSLIMACORPORATE SPA9065.39.1122022-02-12
08033390206716PHYSICA HPSLIMACORPORATE SPA9065.39.1142022-02-12
08033390206723PHYSICA HPSLIMACORPORATE SPA9065.39.1162022-02-12
08033390206730PHYSICA HPSLIMACORPORATE SPA9065.39.1202022-02-12
08033390206747PHYSICA HPSLIMACORPORATE SPA9065.39.2102022-02-12
08033390206754PHYSICA HPSLIMACORPORATE SPA9065.39.2112022-02-12
08033390206761PHYSICA HPSLIMACORPORATE SPA9065.39.2122022-02-12
08033390206778PHYSICA HPSLIMACORPORATE SPA9065.39.2142022-02-12
08033390206877PHYSICA HPSLIMACORPORATE SPA9065.39.2162022-02-12
08033390206884PHYSICA HPSLIMACORPORATE SPA9065.39.2202022-02-12
08033390206891PHYSICA HPSLIMACORPORATE SPA9065.39.3102022-02-12
08033390206907PHYSICA HPSLIMACORPORATE SPA9065.39.3112022-02-12
08033390206914PHYSICA HPSLIMACORPORATE SPA9065.39.3122022-02-12
08033390206921PHYSICA HPSLIMACORPORATE SPA9065.39.3142022-02-12
08033390206938PHYSICA HPSLIMACORPORATE SPA9065.39.3162022-02-12
08033390206945PHYSICA HPSLIMACORPORATE SPA9065.39.3202022-02-12
08033390206952PHYSICA HPSLIMACORPORATE SPA9065.39.4102022-02-12
08033390206969PHYSICA HPSLIMACORPORATE SPA9065.39.4112022-02-12
08033390206976PHYSICA HPSLIMACORPORATE SPA9065.39.4122022-02-12
08033390206983PHYSICA HPSLIMACORPORATE SPA9065.39.4142022-02-12
08033390206990PHYSICA HPSLIMACORPORATE SPA9065.39.4162022-02-12
08033390207003PHYSICA HPSLIMACORPORATE SPA9065.39.4202022-02-12
08033390207010PHYSICA HPSLIMACORPORATE SPA9065.39.5102022-02-12
08033390207027PHYSICA HPSLIMACORPORATE SPA9065.39.5112022-02-12
08033390207034PHYSICA HPSLIMACORPORATE SPA9065.39.5122022-02-12
08033390207041PHYSICA HPSLIMACORPORATE SPA9065.39.5142022-02-12
08033390207058PHYSICA HPSLIMACORPORATE SPA9065.39.5162022-02-12
08033390207065PHYSICA HPSLIMACORPORATE SPA9065.39.5202022-02-12
08033390207072PHYSICA HPSLIMACORPORATE SPA9065.39.6102022-02-12
08033390207089PHYSICA HPSLIMACORPORATE SPA9065.39.6112022-02-12
08033390207096PHYSICA HPSLIMACORPORATE SPA9065.39.6122022-02-12
08033390207102PHYSICA HPSLIMACORPORATE SPA9065.39.6142022-02-12
08033390207119PHYSICA HPSLIMACORPORATE SPA9065.39.6162022-02-12
08033390207126PHYSICA HPSLIMACORPORATE SPA9065.39.6202022-02-12
08033390207133PHYSICA HPSLIMACORPORATE SPA9065.39.7102022-02-12
08033390207140PHYSICA HPSLIMACORPORATE SPA9065.39.7112022-02-12
08033390207157PHYSICA HPSLIMACORPORATE SPA9065.39.7122022-02-12
08033390207164PHYSICA HPSLIMACORPORATE SPA9065.39.7142022-02-12
08033390207171PHYSICA HPSLIMACORPORATE SPA9065.39.7162022-02-12
08033390207188PHYSICA HPSLIMACORPORATE SPA9065.39.7202022-02-12
08033390207195PHYSICA HPSLIMACORPORATE SPA9065.39.8102022-02-12
08033390207201PHYSICA HPSLIMACORPORATE SPA9065.39.8112022-02-12
08033390207218PHYSICA HPSLIMACORPORATE SPA9065.39.8122022-02-12
08033390207225PHYSICA HPSLIMACORPORATE SPA9065.39.8142022-02-12
08033390207232PHYSICA HPSLIMACORPORATE SPA9065.39.8162022-02-12
08033390207249PHYSICA HPSLIMACORPORATE SPA9065.39.8202022-02-12
08033390207256PHYSICA HPSLIMACORPORATE SPA9065.39.9102022-02-12
08033390207263PHYSICA HPSLIMACORPORATE SPA9065.39.9112022-02-12
08033390207270PHYSICA HPSLIMACORPORATE SPA9065.39.9122022-02-12
08033390207287PHYSICA HPSLIMACORPORATE SPA9065.39.9142022-02-12
08033390207294PHYSICA HPSLIMACORPORATE SPA9065.39.9162022-02-12
08033390207300PHYSICA HPSLIMACORPORATE SPA9065.39.9202022-02-12
08033390207317PHYSICA HPSLIMACORPORATE SPA9065.39.A102022-02-12
08033390207324PHYSICA HPSLIMACORPORATE SPA9065.39.A112022-02-12
08033390207331PHYSICA HPSLIMACORPORATE SPA9065.39.A122022-02-12
08033390207348PHYSICA HPSLIMACORPORATE SPA9065.39.A142022-02-12
08033390207355PHYSICA HPSLIMACORPORATE SPA9065.39.A162022-02-12
08033390207362PHYSICA HPSLIMACORPORATE SPA9065.39.A202022-02-12
08033390205986PHYSICA PS PROLIMACORPORATE SPA9065.38.1102022-02-05
08033390206006PHYSICA PS PROLIMACORPORATE SPA9065.38.1112022-02-05