Medacta AMIStem System Biolox Delta Femoral Ball Head. Catalog #01.29.202

Vendor/Manufacturer: Medacta International SA

Product/Product Line: AMIStem System Biolox Delta Femoral Ball Head

Vendor/Manufacturer Catalog #: 01.29.202

Global Unique Device (GUD) Primary Device Identifier Number: 07630030809132

Global Unique Device (GUD) Device Description:

Mectacer Biolox Delta Femoral Ball Head, Femoral Head Ø 28 Size M

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: 888.3353

FDA Regulation Description Classification Name:

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous 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): K112115

The MectaCer Biolox Delta Femoral Ball Head is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Zimmer BIOLOX delta Ceramic Femoral Heads

2. Smith & Nephew Biolox Delta Ceramic Femoral Heads

3. Medacta MectaCer BIOLOX® forte Femoral Heads

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