# K113828: Dynanail Ankle Arthrodesis Nail

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Feb 29, 2012 after 64 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: 3 generations back to K974781 (1998). 7 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 32 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 1.
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K171376: DynaNail TTC Fusion System (2017), 22 descendants of its own
- 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

## Indications for use
The DynaNailtm Ankle Nail is intended for tiblo-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/K113828
Methodology: https://510kreport.com/methodology