# K211891: DM Converter - TiN coated

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 22, 2022 after 396 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: 12 generations back to K941847 (1994). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131458: Mpact DM Liner Converter, Medacta International (2013) Summary page 4.

## Indications for use
The Medacta DM Converter is designed to be used in combination with the Mpact and Versafitcup CC Trio family cementless cups in total hip arthroplasty in 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

Source page: https://510kreport.com/device/K211891
Methodology: https://510kreport.com/methodology