# K083116: Versafit Cup Double Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Apr 7, 2009 after 168 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991990 (1999). 3 ancestors in all.
59 later devices descend from it; 8 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 1.
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 1.

## Most influential descendants
- K101336: E1 Avantage Head (2011), 24 descendants of its own
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own

## Recalls of this device
- May 23, 2011 · Not classified · Z-2709-2011: Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018 Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washing procedures. 
- Jan 15, 2010 · Class II · Z-0878-2013: Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possib

## Indications for use
The Versafit Cup 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 a 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/K083116
Methodology: https://510kreport.com/methodology