# K230088: Ankle Truss System (ATS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: Mar 21, 2024 after 434 days
- Product code: SAI (Ankle Fusion Cage)
- 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: 7 generations back to K951740 (1995). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090857: Valor Ankle Fusion Nail System, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System, Stryker GmbH (2020) Summary page 4.

## Most influential descendants
- K242356: TIDAL Fusion Cage System (2025), 0 descendants of its own

## Indications for use
The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use. The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K230088
Methodology: https://510kreport.com/methodology