# K090988: GMK Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jul 10, 2009 after 94 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941847 (1994). 84 ancestors in all.
52 later devices descend from it; 18 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081023: Evolis Total Knee System, Medacta International S.A. (2008) Summary page 1.
- K072858: TC-Plus Primary Knee System, Smith & Nephew, Inc. (2007) Summary page 1.
- K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions, Zimmer, Inc. (2005) Summary page 1.
- K021657: Uknee Total Knee System, United Orthopedic Corp. (2002) Summary page 1.

## Most influential descendants
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- 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

## Recalls of this device
- Oct 24, 2017 · Class II · Z-0266-2018: Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if 

## 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.

Source page: https://510kreport.com/device/K090988
Methodology: https://510kreport.com/methodology