# K033351: Global Resurfacing Unicompartmental (Gru) Knee

- Pathway: 510(k) (Traditional)
- Applicant: Global Orthopaedic Technology, USA, Inc.
- Decided: Mar 11, 2004 after 143 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condlyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.

Source page: https://510kreport.com/device/K033351
Methodology: https://510kreport.com/methodology