# K262057: GMK Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International SA
- Decided: Sep 15, 2026 after 89 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). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131310: GMK Full PE Tibial Components, Medacta International (2013) Summary page 5.
- K202022: GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE), Medacta International S.A. (2020) Summary page 5.
- K090988: GMK Total Knee System, Medacta International S.A. (2009) Summary page 5.
- K211004: GMK Spherika Femurs and Fixed Tibial Trays Plus, Medacta International S.A. (2021) Summary page 5.
- K133630: GMK Short Stem, Medacta International (2013) Summary page 5.
- K223548: GMK Sphere & GMK SpheriKA Cementless, Medacta International S.A. (2023) Summary page 5.

## Indications for use
The GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components. The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications. The GMK 3D Metal Tibial Baseplate is indicated for cementless or cemented application 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 • Collagen disorders, and avascular necrosis of the femoral condyle • Post traumatic loss of joint configuration • Primary implantation failure Tibial augments cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screw-fixed 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. It is not possible to implant tibial augments, offsets, and extension stems with the GMK 3D Metal Tibial Baseplate and Full PE tibial components. GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for: • 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

Source page: https://510kreport.com/device/K262057
Methodology: https://510kreport.com/methodology