Stryker Triathlon® Total Knee System. Catalog #5517-F-102

Vendor/Manufacturer: Stryker Orthopaedics

Product/Product Line: Triathlon® Total Knee System

Vendor/Manufacturer Catalog #: 5517-F-102

Global Unique Device (GUD) Primary Device Identifier Number: 07613327040913

Global Unique Device (GUD) Device Description:

Cruciate Retaining Femoral

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Coated knee femur prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) 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 may be performed with or without 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):

1. Zimmer Persona® Personalized Knee System

2. Medacta GMK Sphere Knee

For more information, please visit us at Infonomics.com