# K131310: GMK Full PE Tibial Components

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Aug 22, 2013 after 107 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). 95 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K953274: Genesis Porous Tibial Trays & Revision Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K090988: GMK Total Knee System, Medacta International S.A. (2009) Summary page 1.
- K113571: GMK Resufacing Patella Size 4, Medacta International (2012) Summary page 1.
- K120790: GMK - Line Extension, Medacta International (2012) Summary page 1.
- K122232: GMK Narrow, Medacta International (2012) Summary page 1.
- K081023: Evolis Total Knee System, Medacta International S.A. (2008) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.
- K042271: Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular Surfaces, Zimmer, Inc. (2004) Summary page 1.
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 1.

## Most influential descendants
- K262057: GMK Extension (2026), 0 descendants of its own
- K210062: Mectaplug PE II (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. Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. If a semi-constrained insert is used, it is mandatory to implant an extension stem both on the tibial and the femoral components.

Source page: https://510kreport.com/device/K131310
Methodology: https://510kreport.com/methodology