Vendor/Manufacturer: Medacta International SA
Product/Product Line: AMIStem System Biolox Delta Femoral Ball Head
Vendor/Manufacturer Catalog #: 01.29.204
Global Unique Device (GUD) Primary Device Identifier Number: 07630030809156
Global Unique Device (GUD) Device Description:
Mectacer Biolox Delta Femoral Ball Head, Femoral Head Ø 32 Size S
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):
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