# K120531: Versafitcup CC Trio-Additional Liners

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Apr 18, 2012 after 56 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: 10 generations back to K941847 (1994). 149 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103352: Versafitcup CC Trio, Medacta International (2011) Summary page 1.
- K103721: Mpact Acetabular System, Medacta International (2011) Summary page 1.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 1.

## Most influential descendants
- K122911: Versafitcup CC Trio Extension (2012), 1 descendant of its own
- K250450: Coated hip implants (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.

Source page: https://510kreport.com/device/K120531
Methodology: https://510kreport.com/methodology