Medacta AMIStem System CoCr Femoral Ball Head. Catalog #01.25.012

Vendor/Manufacturer: Medacta International SA

Product/Product Line: AMIStem System CoCr Femoral Ball Head

Vendor/Manufacturer Catalog #: 01.25.012

Global Unique Device (GUD) Primary Device Identifier Number: 07630030805110

Global Unique Device (GUD) Device Description:

CoCr Femoral Ball Head, Femoral Head Ø 28 size M

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic 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 metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. 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 articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). 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: 888.3350

FDA Regulation Description Classification Name:

Hip joint metal/polymer semi-constrained cemented prosthesis

FDA Classification Product Code(s): JDI

FDA Classification Product Code Device Name(s):

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

FDA Premarket Submission(s): K080885 , K072857

The Medacta AMIStem System CoCr Femoral Ball Head is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Portland Orthopaedics Cobalt Chrome Femoral Head

2. Medacta Total Hip Prosthesis System

For more information, please visit us at Infonomics.com