# K173811: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones Sas
- Decided: Mar 15, 2018 after 90 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982953 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL, Newdeal Sas (2009) Summary page 5.
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 5.

## Most influential descendants
- K250622: Succession™ AFN System (2025), 0 descendants of its own

## Indications for use
The TRIWAY® TTC Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: • Post-traumatic and degenerative arthritis involving both ankle and subtalar joints • Rheumatoid arthritis with severe deformity • Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body • Revision of failed total ankle arthroplasty with subtalar intrusion • Talar deficiency conditions, including avascular necrosis (requiring a tibiocalcaneal arthrodesis) • Neuroarthropathy or neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, including Charcot foot • Severe pilon fractures with trauma to the subtalar joint • Malunited tibial pilon fractures The addition of an IBS™ 6.5mm compression screw through the subtalar joint and through the nail is required.

Source page: https://510kreport.com/device/K173811
Methodology: https://510kreport.com/methodology