# K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 12, 2010 after 226 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 4 generations back to P960047 (1997). 24 ancestors in all.
23 later devices descend from it; 7 cite it directly.
0 of 48 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 1.
- K071718: Trilogy Longevity Constrained Liner, Zimmer, Inc. (2007) Summary page 1.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 1.
- K030923: Epsilon Durasul Constrained Acetabular Liner, Centerpulse Orthopedics, Inc. (2003) Summary page 1.
- K021911: Trident Crossfire Polyuethylene Liners, Howmedica Osteonics Corp. (2002) Summary page 2.
- K994415: Marathon Cross-Linked Polyethylene Acetabular Cup Liners, DePuy Orthopaedics, Inc. (2000) Summary page 2.
- K990135: Trilogy Acetabular System Longevity Crosslinked Polyethylene, Zimmer, Inc. (1999) Summary page 2.

## Most influential descendants
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K122641: Mpact Extension (2012), 14 descendants of its own
- K132879: Mpact Extension (2014), 11 descendants of its own
- K183582: MPACT Extension (2019), 4 descendants of its own
- K103352: Versafitcup CC Trio (2011), 4 descendants of its own

## Indications for use
The Versafitcup Double Mobility Family is intended for cementless use in total hip arthroplasty 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 * 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. * Dislocation risks

Source page: https://510kreport.com/device/K092265
Methodology: https://510kreport.com/methodology