# K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000

- Pathway: 510(k) (Traditional)
- Applicant: Medshape Solutions
- Decided: Aug 3, 2011 after 387 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: 2 generations back to K974781 (1998). 6 ancestors in all.
25 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)
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K113828: Dynanail Ankle Arthrodesis Nail (2012), 24 descendants of its own
- 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

## Indications for use
The DynaNail Ankle Nail is intended for tibia-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/K101934
Methodology: https://510kreport.com/methodology