# K130051: 611 Ankle Fusion Nail

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Jul 15, 2013 after 187 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.
No later device cites it as a predicate yet.
0 of 3 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) Summary page 3.
- K051678: Synthes Hindfoot Arthrodesis Nail System, Synthes (Usa) (2005) Summary page 1.

## Indications for use
The immobilization of the ankle with the 611 Ankle Fusion Nail is indicated in the following cases: - Severe defects of the ankle and subtalar joints and/or deformations with/without instability, - Avascular necrosis of the talus, - Traumatic or post-traumatic involvement of the ankle and subtalar joints, - Degenerative pathologies: primary or post-trauma osteoarthritis, rheumatoid polyarthritis. - Revision of the arthrodesis or revision of the total ankle prosthesis, - Neuroarthropathy or neuropathic deformation of the ankle/Charcot Foot.

Source page: https://510kreport.com/device/K130051
Methodology: https://510kreport.com/methodology