# K241767: Versacem Acetabular Shell and Double Mobility HC Liners

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 6, 2025 after 259 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: 13 generations back to K941847 (1994). 148 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model, Serf (2011) Summary page 5.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 5.
- K131458: Mpact DM Liner Converter, Medacta International (2013) Summary page 5.
- K143453: Mpact Double Mobility System, Medacta International (2015) Summary page 5.

## Indications for use
Versacem is designed for use In total hip arthroplasty, for selected primary or revision surgery. 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. Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases: Elderly patients or poor bone quality. Revision for recurrent dislocation in elderly patients with poor bone quality. Patients treated with radiotherapy or chemotherapy. Versacem is intended for cemented use only.

Source page: https://510kreport.com/device/K241767
Methodology: https://510kreport.com/methodology