# K120419: Dyna Locking Ankle Nail

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: May 21, 2012 after 101 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 K982953 (1998). 4 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860756: Grosse and Kempf Locking Nail System, Non-Slot Rod, Howmedica Corp. (1986) Summary page 1.
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005) Summary page 2.
- K021786: Titanium Ankle Arthrodesis Nail, Biomet, Inc. (2002) Summary page 1.

## 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
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own

## Indications for use
The Dyna Locking Ankle Nailm is used in various indications as follows. * Post-traumatic and degenerative arthritis involving both ankle and subtalar joints * Rheumatoid arthritis * Revision of failed ankle arthrodesis with subtalar involvement of with an insufficient talar body * Revision of failed total ankle arthroplasty with subtalar intrusion * Talar deficiency conditions requiring tibiocalcaneal arthrodesis * Avascular necrosis of the talus * Neuroarthropathy or neuropathic ankle deformity * Severe deformity as a result of talipes equionovarus, cerebral vascular accident, paralysis of other neuromuscular disease * Severe pilon fractures with trauma to the subtalar joint

Source page: https://510kreport.com/device/K120419
Methodology: https://510kreport.com/methodology