# K200108: GEO 1st MTP Joint Arthrodesis Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Gramercy Extremity Orthopedics, LLC
- Decided: Mar 26, 2020 after 69 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 1 generation back to K041287 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041287: Vilex Bone Plate System, Vilex, Inc. (2004) Summary page 4.

## Most influential descendants
- K210534: GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System (2021), 0 descendants of its own

## Recalls of this device
- Apr 4, 2023 · Class II · Z-1395-2023: Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.

## Indications for use
The GEO 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/K200108
Methodology: https://510kreport.com/methodology