# K242356: TIDAL Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D, Inc.
- Decided: Mar 24, 2025 after 228 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: 8 generations back to K951740 (1995). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171376: DynaNail TTC Fusion System, MedShape, Inc. (2017) Summary page 5.
- K230088: Ankle Truss System (ATS), 4Web Medical, Inc. (2024) Summary page 5.

## Indications for use
The TIDAL Fusion Cage System is intended to be used as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk of limb loss. The TIDAL Fusion Cage System is intended for use as an accessory to the DynaNail TTC Fusion System. The TIDAL Fusion Cage System is not intended for standalone use. The TIDAL Fusion Cage System is intended for use with autograft and/or allogenic bone graft.

Source page: https://510kreport.com/device/K242356
Methodology: https://510kreport.com/methodology