Mpact 3D Metal Augments II

The Mpact 3D Metal Augments II is an acetabular implant made of titanium alloy (Ti6Al4V) for use in total hip arthroplasty. It is cemented to a compatible Medacta acetabular shell and used cementless at the bone interface. It is indicated for acetabular dysplasia, acetabular fractures, and revision surgery with insufficient bone quality.

The subject device shares cementation method, material composition, manufacturing process, surface finishing, three-dimensional porous net structure, packaging, shelf-life, and sterilization with the predicate Mpact 3D Metal Augments (K171966). It differs in size range (Ø46 to Ø80), device design, and introduces a new Double Augment Technique Screw allowing two augments to be attached together, whereas the predicate was used only as a single augment.

ASTM F2924 for titanium alloy composition, ISO 5832-3 for screw material, ISO 11737-3 and European Pharmacopoeia §2.6.14 for bacterial endotoxin testing, and USP <151> for in-vivo pyrogenicity testing in rabbits.

The device shares the same core technology, material, manufacturing process, and intended use as the predicate device. Design validation and fatigue testing in both single and double augment configurations demonstrate performance comparable to the predicate. The differences in size range and the addition of the double augment screw are design enhancements that maintain the fundamental intended function and do not raise new safety or effectiveness questions beyond the substantially equivalent predicate.