# K193366: T2 ICF

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Mar 20, 2020 after 107 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: 12 generations back to K962616 (1996). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081071: Synthes 6.5MM Midfoot Fusion Bolt, Synthes (Usa) (2008) Summary page 4.
- K180024: SALVATION Midfoot Nail, Wrightmedicaltechnologyinc (2018) Summary page 4.

## Most influential descendants
- K211261: Axis Charcot Fixation System (2021), 0 descendants of its own

## Indications for use
The T2 ICF System is indicated for internal bone fixation of the foot for the following conditions and procedures: » Neuropathic osteoarthropathy (Charcot) * Fracture fixation » Osteotomies * Non-unions » Mal-unions * Fusions

Source page: https://510kreport.com/device/K193366
Methodology: https://510kreport.com/methodology