# K112982: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Apr 2, 2012 after 179 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: 1 generation back to K051590 (2005). 2 ancestors in all.
11 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)
- K051590: T2 Ankle Arthrodesis Nail, Howmedica Osteonics Corp. (2005)
- K051678: Synthes Hindfoot Arthrodesis Nail System, Synthes (Usa) (2005)

## Most influential descendants
- K130147: Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail) (2013), 9 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 SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following: - Post traumatic and degenerative arthritis involving both ankle and subtalar joints, - Rheumatoid arthritis, - Osteoarthritis, - Pseudoarthrosis, - Severe foot/ankle deformity, or - Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

Source page: https://510kreport.com/device/K112982
Methodology: https://510kreport.com/methodology