Vendor/Manufacturer: Stryker Orthopaedics
Product/Product Line: Triathlon® Total Knee System
Vendor/Manufacturer Catalog #: 5575-X-000
Global Unique Device (GUD) Primary Device Identifier Number: 07613327050011
Global Unique Device (GUD) Device Description:
Femoral Distal Fixation Peg
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Uncoated knee femur prosthesis, metallic
Global Medical Device Nomenclature (GMDN) Definition:
An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3560
FDA Regulation Description Classification Name:
Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis
FDA Classification Product Code(s): MBH, JWH
FDA Classification Product Code Device Name(s):
MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA Premarket Submission(s): K201343
The Stryker Triathlon® Total Knee System is
SUBSTANTIALLY EQUIVALENT to the following product(s):
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