# K143453: Mpact Double Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Mar 2, 2015 after 89 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: 12 generations back to K941847 (1994). 146 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 4.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 4.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 4.
- K132879: Mpact Extension, Medacta International (2014) Summary page 4.
- K131458: Mpact DM Liner Converter, Medacta International (2013) Summary page 4.

## Most influential descendants
- K241767: Versacem Acetabular Shell and Double Mobility HC Liners (2025), 0 descendants of its own

## Indications for use
The hip prosthesis is 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 psoriactic 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. • Dislocation risks

Source page: https://510kreport.com/device/K143453
Methodology: https://510kreport.com/methodology