Stryker Triathlon® Total Knee System. Catalog #5520-B-300

Vendor/Manufacturer: Stryker Orthopaedics

Product/Product Line: Triathlon® Total Knee System

Vendor/Manufacturer Catalog #: 5520-B-300

Global Unique Device (GUD) Primary Device Identifier Number: 07613327050318

Global Unique Device (GUD) Device Description:

PRIMARY Tibial Baseplate

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Uncoated knee tibia prosthesis, metallic

Global Medical Device Nomenclature (GMDN) Definition:

An implantable device designed to replace the tibial condyles (tibial 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 an insert and/or the femoral prosthetic component 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):

1. Zimmer Persona® Personalized Knee System

2. Medacta GMK Sphere Knee

For more information, please visit us at Infonomics.com