# K180087: A.M. Surgical Intramedullary Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: A.M. Surgical, Inc.
- Decided: May 18, 2018 after 126 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Intramedullary Fixation Device is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

Source page: https://510kreport.com/device/K180087
Methodology: https://510kreport.com/methodology