# K241461: Mpact Constrained Liner

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 31, 2025 after 434 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 154 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061654: Trident Constrained Acetabular Insert, Howmedica Osteonics Corp. (2006) Summary page 5.
- K111635: Smith & Nephew RJ Constrained Liners, Smith & Nephew, Inc. (2011) Summary page 5.
- K091967: Medacta Bipolar Head, Medacta International S.A. (2010) Summary page 5.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 5.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 5.

## Most influential descendants
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own

## Indications for use
Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells. Total Hip Arthroplasty 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 or neck Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.

Source page: https://510kreport.com/device/K241461
Methodology: https://510kreport.com/methodology