# K210010: GMK Revision & Hinge Extension - TiNbN Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Mar 2, 2021 after 57 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K941847 (1994). 133 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 5.
- K103170: GMK Revision Knee SC Liners, Medacta International S.A. (2011) Summary page 5.
- K123721: GMK Revision Extension, Medacta International (2013) Summary page 5.
- K130299: GMK Hinge, Medacta International (2013) Summary page 5.
- K163311: GMK Revision Femoral Distal Augmentation, Medacta International S.A. (2016) Summary page 5.
- K172347: GMK Hinge, GMK Revision, Medacta International S.A. (2017) Summary page 5.
- K202684: GMK Total Knee System - TiNbN Coating, Medacta International S.A. (2020) Summary page 5.

## Most influential descendants
- K211664: GMK Sphere Revision (2021), 0 descendants of its own

## 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, 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 The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis. The GMK® HINGE knee system is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability • Considerable loss of function of the knee joint • High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation • Failure of a primary prosthesis (e.g. infection, loosening) • Former revision arthroplasty • Post traumatic loss of joint configuration • Avascular necrosis of femoral condyle. Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws. When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

Source page: https://510kreport.com/device/K210010
Methodology: https://510kreport.com/methodology