Medacta M-VIZION Femoral Hip Revision System. Catalog #01.22.115

Vendor/Manufacturer: Medacta International SA

Product/Product Line: M-Vizion Femoral Revision System

Vendor/Manufacturer Catalog #: 01.22.115

Global Unique Device (GUD) Primary Device Identifier Number: 07630971240896

Global Unique Device (GUD) Device Description:

Distal Stem Ø26mm L 140mm straight

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Revision coated hip femur prosthesis

Global Medical Device Nomenclature (GMDN) Definition:

A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

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):

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission(s): K170690 , K191816

The Medacta M-VIZION Femoral Hip Revision System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Zimmer Wagner Cone Prosthesis® System

2. Zimmer Wagner SL Revision Stem Lateral

3. Limacorporate S.p.A. Revision Femoral Stem

4. Medacta International MasterLoc Stem

For more information, please visit us at Infonomics.com