Stryker Trident® Acetabular System. Catalog #6570-0-028

Vendor/Manufacturer: Stryker

Product/Product Line: Trident® Acetabular System

Vendor/Manufacturer Catalog #: 6570-0-028

Global Unique Device (GUD) Primary Device Identifier Number: 04546540608468

Global Unique Device (GUD) Device Description:

V40 Taper BIOLOX delta Ceramic Heads, Ceramic V40 Femoral Head

Global Medical Device Nomenclature (GMDN) Preferred Term Name: Ceramic femoral head prosthesis Global Medical Device Nomenclature (GMDN) Definition: An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices FDA Regulation Number: 888.3358 FDA Regulation Description Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

FDA Classification Product Code(s): LZO FDA Classification Product Code Device Name(s): LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

FDA Premarket Submission(s): K061434 , K062419 , K061654 , K021310 , K02207, K052718 The Trident® large diameter and constrained acetabular inserts and LFIT femoral heads and are SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Sulzer Orthopaedics Inter-Op Durasul Acetabular System

2. Biomet Freedom Constrained Acetabular Insert

3. Stryker Howmedica Osteonics Contemporary Cup

4. Stryker Howmedica Osteonics LFIT cobalt chrome femoral heads

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