# K123721: GMK Revision Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jul 26, 2013 after 234 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K941847 (1994). 88 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090988: GMK Total Knee System, Medacta International S.A. (2009) Summary page 1.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 1.
- K120790: GMK - Line Extension, Medacta International (2012) Summary page 1.

## Most influential descendants
- K172347: GMK Hinge, GMK Revision (2017), 2 descendants of its own
- K210010: GMK Revision & Hinge Extension - TiNbN Coating (2021), 1 descendant of its own
- K211664: GMK Sphere Revision (2021), 0 descendants of its own

## Indications for use
The Evolis/GMKcD knee prosthesis is designed for cemented use in total knee arthropiasty, 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. Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

Source page: https://510kreport.com/device/K123721
Methodology: https://510kreport.com/methodology