Medacta MPACT® Double Mobility System Acetabular Shell. Catalog #01.32.150MB

Vendor/Manufacturer: Medacta International SA

Product/Product Line: MPACT® Double Mobility System Acetabular Shell

Vendor/Manufacturer Catalog #: 01.32.150MB

Global Unique Device (GUD) Primary Device Identifier Number: 07630030860966

Global Unique Device (GUD) Device Description:

Mpact Double Mobility Shells, Double Mobility Acetabular shell Ø50

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): LPH, LZO, MEH

FDA Classification Product Code Device Name(s):

LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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

MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

FDA Premarket Submission(s): K143453 , K103721

The Medacta MPACT® Double Mobility System Acetabular Shell is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Medacta Versafitcup Double Mobility

2. Medacta Versafitcup DM Highly Crosslinked

3. Medacta Mpact Acetabular System

4. Medacta Mpact Extension

5. Medacta Mpact DM Converter

6. DePuy Pinnacle®D with Gription Acetabular Cups

7. DePuy Pinnacle® Acetabular System

8. Smith & Nephew REFLECTION 3 Acetabular System

9. Omni Lifesciences Apex Modular Heads, +10.5 mm offset

10. Medacta Bone Screws

11. Medacta Total Hip Prosthesis

12. Medacta Total Hip Prosthesis CoCrMo ball heads

13. Medacta Versafitcup® Double Mobility HighCross® UHMWPE Liners

14. Omni Lifesciences Apex- LNK Poly Acetabular Liners and Apex Modular Head, 40 min

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