# K211664: GMK Sphere Revision

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 29, 2021 after 58 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: 17 generations back to K941847 (1994). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121416: GMK Sphere, Medacta International (2012) Summary page 4.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 4.
- K123721: GMK Revision Extension, Medacta International (2013) Summary page 4.
- K202684: GMK Total Knee System - TiNbN Coating, Medacta International S.A. (2020) Summary page 4.
- K210010: GMK Revision & Hinge Extension - TiNbN Coating, Medacta International S.A. (2021) Summary page 4.

## Indications for use
The Evolis® GMK® knee prosthesis 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, theumatoid 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 or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

Source page: https://510kreport.com/device/K211664
Methodology: https://510kreport.com/methodology