# K202684: GMK Total Knee System - TiNbN Coating

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Dec 11, 2020 after 87 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: 15 generations back to K941847 (1994). 122 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 125 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 4.
- K120790: GMK - Line Extension, Medacta International (2012) Summary page 4.
- K121416: GMK Sphere, Medacta International (2012) Summary page 4.
- K122232: GMK Narrow, Medacta International (2012) Summary page 4.
- K140826: GMK Sphere Extension, Medacta International (2014) Summary page 4.
- K142069: GMK Extension, Medacta International (2014) Summary page 4.
- K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating, Waldemar Link GmbH & Co. KG (2016) Summary page 4.

## Most influential descendants
- K210010: GMK Revision & Hinge Extension - TiNbN Coating (2021), 1 descendant of its own
- K211664: GMK Sphere Revision (2021), 0 descendants of its own
- K203755: Shoulder System - TiNbN Coating (2021), 0 descendants of its own

## Indications for use
The GMK 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. GMK Sphere can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, 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. * Collagen disorders, and/or avascular necrosis of the femoral condyle. * Moderate valgus, varus, or flexion deformities. Cemented tibial wedges 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 the case of a semi-constrained liner is being used, an extension stem must be implanted both on the tibial and on the femoral components. In the case a GMK Revision tibial tray is being used, an extension stem must be implanted.

Source page: https://510kreport.com/device/K202684
Methodology: https://510kreport.com/methodology