# K171376: DynaNail TTC Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Nov 2, 2017 after 176 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 K974781 (1998). 8 ancestors in all.
22 later devices descend from it; 7 cite 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)
- K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000, Medshape Solutions (2011) Summary page 4.
- K113828: Dynanail Ankle Arthrodesis Nail, MedShape, Inc. (2012) Summary page 4.

## Most influential descendants
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K182677: DynaNail Mini (2019), 5 descendants of its own

## Indications for use
The DynaNail TTC Fusion System is intended for tibio-talo-calcaneal 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/K171376
Methodology: https://510kreport.com/methodology