Stryker Triathlon® Total Knee System. Catalog #5550-L-391

Vendor/Manufacturer: Stryker Orthopaedics

Product/Product Line: Triathlon® Total Knee System

Vendor/Manufacturer Catalog #: 5550-L-391

Global Unique Device (GUD) Primary Device Identifier Number: 07613327050240

Global Unique Device (GUD) Device Description:

Patella

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Polyethylene patella prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella 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