# K133630: GMK Short Stem

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Dec 20, 2013 after 24 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: 13 generations back to K941847 (1994). 94 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 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.
- K121416: GMK Sphere, Medacta International (2012) Summary page 1.
- K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions, Zimmer, Inc. (2005) Summary page 1.

## Most influential descendants
- K262057: GMK Extension (2026), 0 descendants of its own

## Indications for use
The GMVK 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 augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

Source page: https://510kreport.com/device/K133630
Methodology: https://510kreport.com/methodology