# K251043: Mpact 3D Metal Implants Extension – DMLS Technology

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jan 28, 2026 after 300 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941847 (1994). 240 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202568: Mpact® 3D Metal Implants - DMLS Technology, Medacta International S.A. (2021) Summary page 5.
- K230011: Mpact Extension, Medacta International S.A. (2023) Summary page 5.
- K103352: Versafitcup CC Trio, Medacta International (2011) Summary page 5.

## Indications for use
The Mpact 3D Metal implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient’s condition should be due to one or more of: • Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Source page: https://510kreport.com/device/K251043
Methodology: https://510kreport.com/methodology