# K950864: GTS Great Toe System - (Metatarsal Component with Porous Coating)

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Jul 31, 1995 after 154 days
- Product code: LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained)
- Device class: U
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K950864
Methodology: https://510kreport.com/methodology