# K103170: GMK Revision Knee SC Liners

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Mar 24, 2011 after 148 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: 10 generations back to K941847 (1994). 86 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 114 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). Our reading of the summary gave K090958, FDA’s number for Inomax DS (Delivery System) (Ino Therapeutics, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GMK Total Knee System”. Summary page 2.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 2.

## Most influential descendants
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own
- K121416: GMK Sphere (2012), 20 descendants of its own
- K140826: GMK Sphere Extension (2014), 17 descendants of its own
- K120790: GMK - Line Extension (2012), 11 descendants of its own
- K162035: GMK Sphere (2017), 10 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. The 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/K103170
Methodology: https://510kreport.com/methodology