Vendor/Manufacturer: Stryker Orthopaedics
Product/Product Line: Triathlon® Total Knee System
Vendor/Manufacturer Catalog #: 5532-G-619
Global Unique Device (GUD) Primary Device Identifier Number: 07613327050882
Global Unique Device (GUD) Device Description:
Tibial Bearing Insert - PS
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Tibial insert
Global Medical Device Nomenclature (GMDN) Definition:
An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.
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):
For more information, please visit us at Infonomics.com
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