# K240175: Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

- Pathway: 510(k) (Traditional)
- Applicant: Tigon Medical
- Decided: Oct 29, 2024 after 280 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: 6 generations back to K000684 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083096: Latarjet Cortical Screw Set, Tag Medical Products (2009) Summary page 5.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 5.

## Indications for use
The Tigon Medical FIRE System is intended to provide the orthopedic surgeon with a means of bone-to-bone fixation and to assist in the management of reconstructive surgeries. - Bone Loss Deficiencies/Deformities * Latarjet * Free bone block - Internal bone fixation for bone fractures, fusions, non-unions, and osteotomies in the foot, ankle, hand, and wrist.

Source page: https://510kreport.com/device/K240175
Methodology: https://510kreport.com/methodology