Medacta MPACT® Acetabular System. Catalog #01.32.6515

Vendor/Manufacturer: Medacta International SA

Product/Product Line: MPACT® Acetabular System

Vendor/Manufacturer Catalog #: 01.32.6515

Global Unique Device (GUD) Primary Device Identifier Number: 07630030812361

Global Unique Device (GUD) Device Description:

Mpact Acetabular System, Cancellous bone screw flat head Ø 6,5 L15

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic bone screw, non-bioabsorbable, sterile

Global Medical Device Nomenclature (GMDN) Definition:

A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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

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

FDA Premarket Submission(s): K132879 , K103721

The Medacta MPACT® Acetabular System Cancellous Bone Screw is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. DePuy Pinnacle® Revision Cup System

2. Medacta MPACT® Extension

3. DePuy Pinnacle®D with Gription Acetabular Cups

4. DePuy Pinnacle® Acetabular System

5. Smith & Nephew REFLECTION 3 Acetabular System

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

7. Medacta Bone Screws

8. Medacta Total Hip Prosthesis

9. Medacta Total Hip Prosthesis CoCrMo ball heads

10. Medacta Versafitcup® Double Mobility

11. Medacta Versafitcup® Double Mobility HighCross® UHMWPE Liners

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

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