# K103352: Versafitcup CC Trio

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Feb 11, 2011 after 87 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: 9 generations back to K941847 (1994). 121 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component, Exactech, Inc. (1999) Summary page 2.
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 2.
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 2.
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners, Medacta International S.A. (2010) Summary page 2.
- K091069: Medacta Bone Screws - Evolis and Versafit, Medacta International S.A. (2009) Summary page 2.
- K003758: Allofit Acetabular System, Sulzer Orthopedics, Inc. (2001) Summary page 2.

## Most influential descendants
- K120531: Versafitcup CC Trio-Additional Liners (2012), 2 descendants of its own
- K122911: Versafitcup CC Trio Extension (2012), 1 descendant of its own
- K251043: Mpact 3D Metal Implants Extension – DMLS Technology (2026), 0 descendants of its own
- K250450: Coated hip implants (2025), 0 descendants of its own

## Indications for use
The Versafitcup® CC Trio is intended for cementiess use in total hip arthropfasty and 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, or 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, hemniarthroplasty, surface replacement arthropiasty, or total hip replacement where sufficient bone stock is present.

Source page: https://510kreport.com/device/K103352
Methodology: https://510kreport.com/methodology