Stryker Trident® Acetabular System. Catalog #542-11-42B

Vendor/Manufacturer: Stryker

Product/Product Line: Trident® Acetabular System

Vendor/Manufacturer Catalog #: 542-11-42B

Global Unique Device (GUD) Primary Device Identifier Number: 04546540240446

Global Unique Device (GUD) Device Description:

Trident PSL HA Cluster Shells, Cluster Acetabular Shell

Global Medical Device Nomenclature (GMDN) Preferred Term Name: Acetabular shell Global Medical Device Nomenclature (GMDN) Definition: An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

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): JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MBL, MEH FDA Classification Product Code Device Name(s): JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented KWL: Prosthesis, hip, hemi-, femoral, metal KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate FDA Premarket Submission(s): K061434 , K062419 , K061654 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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