# K081755: Fusion Medical Sti

- Pathway: 510(k) (Traditional)
- Applicant: John Riccio
- Decided: May 20, 2009 after 334 days
- Product code: HWC (Screw, Fixation, Bone)
- 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
Longest line of descent: 3 generations back to K792670 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031155: Osteomed Subtalar Implant System, Osteomed LP (2003) Summary page 1.
- K032902: Subtalar Arthrorisis Implant, Nexa Orthopedics, Inc. (2003) Summary page 2.

## Indications for use
The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalarjoint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela. Examples are: Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.

Source page: https://510kreport.com/device/K081755
Methodology: https://510kreport.com/methodology