# K130299: GMK Hinge

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Aug 15, 2013 after 189 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915192 (1992). 20 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003504: RT-Plus Modular Cemented Knee Components, Plus Orthopedics (2001) Summary page 2.
- K013385: Nexgen Complete Knee Solution Rotatng Hinge Knee, Zimmer, Inc. (2002) Summary page 2.
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 2.
- K101815: Enduro Knee System, Aesculap Implant Systems (2010) Summary page 2.
- K896048: S-Rom/Noiles Mark 3, Joint Medical Products Corp. (1990) Summary page 2.

## Most influential descendants
- K172347: GMK Hinge, GMK Revision (2017), 2 descendants of its own
- K163311: GMK Revision Femoral Distal Augmentation (2016), 2 descendants of its own
- K210010: GMK Revision & Hinge Extension - TiNbN Coating (2021), 1 descendant of its own
- K211664: GMK Sphere Revision (2021), 0 descendants of its own

## Recalls of this device
- May 19, 2017 · Class II · Z-2661-2017: One lot of product does not include a screw for attachment to the tibial base plate.
- Apr 17, 2015 · Class II · Z-0275-2016: Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

## Indications for use
The GMK HINGE® knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis. The GMK HINGE® knee system is indicated in the following cases: * Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability * Considerable loss of function of the knee joint * High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation * Failure of a primary prosthesis (e.g. infection, loosening) * Former revision arthroplasty * Post traumatic loss of joint configuration * Avascular necrosis of femoral condyle Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws. When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

Source page: https://510kreport.com/device/K130299
Methodology: https://510kreport.com/methodology