# K210263: Mpres Neck Preserving Stem

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 22, 2021 after 233 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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: 9 generations back to K955033 (1996). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083312: Minihip Stem, Corin USA (2010) Summary page 4.

## Most influential descendants
- K250450: Coated hip implants (2025), 0 descendants of its own

## Indications for use
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery. Total Hip Arthroplasty with the Mpres stem is indicated in the following cases: » Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. * Avascular necrosis of the femoral head. * Acute traumatic fracture of the femoral head. » Failure of previous hip surgery: o Conservative hip surgery, o Internal fixation, o Arthrodesis, o Hip resurfacing replacement. Partial hip arthroplasty with the Mpres stem is indicated in the following cases: * Acute traumatic fracture of the femoral head. * Avascular necrosis of the femoral head. * Primary pathology involving the femoral head but with a non-deformed acetabulum.

Source page: https://510kreport.com/device/K210263
Methodology: https://510kreport.com/methodology