# K091069: Medacta Bone Screws - Evolis and Versafit

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jun 1, 2009 after 48 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941847 (1994). 88 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011719: Plus Cancellous Bone Screws, Plus Orthopedics (2001) Summary page 1.
- K081023: Evolis Total Knee System, Medacta International S.A. (2008) Summary page 1.

## 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 Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis avascular necrosis of femoral condyle post traumatic loss of joint configuration. primary implantation failure.

Source page: https://510kreport.com/device/K091069
Methodology: https://510kreport.com/methodology