# K250628: DynaNail TTC Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Sep 12, 2025 after 193 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: 5 generations back to K974781 (1998). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal fusions: * Post-traumatic and degenerative arthritis. * Post-traumatic or primary arthrosis involving both ankle and subtalar joints. * Revision after failed ankle arthrodesis with subtalar involvement. * Failed total ankle arthroplasty. * Non-union ankle arthrodesis. * Rheumatoid hindfoot. » Absent Talus (requiring tibiocalcaneal arthrodesis). » Avascular necrosis of the talus. * Neuroarthropathy or neuropathic ankle deformity. * Neuromuscular disease and severe deformity. * Osteoarthritis. * Charcot Foot. * Previously infected arthrosis, second degree.

Source page: https://510kreport.com/device/K250628
Methodology: https://510kreport.com/methodology