Mpact 3D Metal Implants Extension – DMLS Technology

The Mpact 3D Metal Implants Extension – DMLS Technology are acetabular shells used in total hip arthroplasty (hip replacement) for cementless fixation in primary or revision surgery. They are manufactured using Direct Metal Laser Sintering (DMLS) with titanium alloy and replace the hip joint's acetabulum (socket). The devices are intended for skeletally mature patients with conditions including osteoarthritis, avascular necrosis, traumatic fracture, or failed prior hip surgery.

The subject devices are similar to the predicate device (K202568) in design, fixation, material, biocompatibility, usage, packaging, sterilization, and shelf-life. They differ in the range of product sizes (Ø42T to Ø58T), compatibility with larger liners, a partially different manufacturing process with identical chemicals/agents, and pyramidal net height. The size extension allows optimization of head-to-shell ratio to reduce dislocation risk.

ASTM F3090-24 (fatigue), EN ISO 21535 (range of motion), ASTM F1854-15 (stereological evaluation), ASTM F1147-05 (tension testing), ASTM F1044-05 (shear testing), ASTM F1160-14 (fatigue shear), ASTM F1978-22 (abrasion), ASTM F2582-20 (impingement), ISO 7206-12 (deformation), European Pharmacopoeia §2.6.14 (endotoxin), USP chapter <151> (pyrogenicity), ISO 11607-1 and 11607-2 (shelf-life packaging).

The subject devices are substantially equivalent because they share the same fundamental design, material, intended use, manufacturing technology, and performance characteristics as the predicate device K202568. Differences in size range, liner compatibility, and minor manufacturing process variations do not raise new safety or effectiveness issues, as demonstrated by comprehensive mechanical testing. The expanded size range is supported by the additional predicate device K230011, which uses the same approach.