# K251166: Mfinity Femoral System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jun 13, 2025 after 59 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K941847 (1994). 228 ancestors in all.
No later device cites it as a predicate yet.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210581: Actis DuoFix Hip Prosthesis- Collarless, Depuy Ireland UC (2021) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K192827: Quadra-P, Medacta International S.A. (2020) Summary page 5.
- K181254: Quadra P, Medacta International S.A. (2018) Summary page 5.
- K173794: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, Medacta International S.A. (2018) Summary page 5.

## Indications for use
Mfinity femoral stems are indicated in patients requiring hip arthroplasty. Hip Arthroplasty Total or partial hip arthroplasty is indicated in the following cases: • Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia. • Avascular necrosis of the femoral head. • Acute fracture of the femoral head. • Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty. • Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty. • Primary pathology involving the femoral head but with a non-deformed acetabulum. • Failure of previous hip surgery: o Conservative hip surgery. o Internal fixation. o Arthrodesis. o Partial or total hip arthroplasty. o Hip resurfacing replacement.

Source page: https://510kreport.com/device/K251166
Methodology: https://510kreport.com/methodology