# K210534: GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

- Pathway: 510(k) (Special)
- Applicant: Gramercy Extremity Orthopedics, LLC
- Decided: Mar 26, 2021 after 30 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041287 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200108: GEO 1st MTP Joint Arthrodesis Plating System, Gramercy Extremity Orthopedics, LLC (2020) Summary page 4.
- K041287: Vilex Bone Plate System, Vilex, Inc. (2004) Summary page 4.

## Indications for use
The GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is indicated for use in the stabilization and fixation of the first metatarsal-phalangeal joint in the foot for surgical fusion (arthrodesis), osteotomy, nonunion, malunion or revision surgery.

Source page: https://510kreport.com/device/K210534
Methodology: https://510kreport.com/methodology