# K113571: GMK Resufacing Patella Size 4

- Pathway: 510(k) (Special)
- Applicant: Medacta International
- Decided: Jan 27, 2012 after 56 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: 11 generations back to K941847 (1994). 88 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 111 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.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K102437: GMK Revision Knee System, Medacta International S.A. (2010) Summary page 1.
- K103170: GMK Revision Knee SC Liners, Medacta International S.A. (2011) Summary page 1.
- K081023: Evolis Total Knee System, Medacta International S.A. (2008) Summary page 1.
- (no number) Medacta GMK Resurfacing Patellas (Sizes 1, 2, 3): named in the summary without a submission number

## Most influential descendants
- K121416: GMK Sphere (2012), 20 descendants of its own
- K140826: GMK Sphere Extension (2014), 17 descendants of its own
- K162035: GMK Sphere (2017), 10 descendants of its own
- K173890: GMK Sphere - Kinematic Alignment (2018), 6 descendants of its own
- K211004: GMK Spherika Femurs and Fixed Tibial Trays Plus (2021), 4 descendants of its own

## Indications for use
The GMK 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. * rimary 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/K113571
Methodology: https://510kreport.com/methodology