# K141571: Orthofix Ankle Hindfoot Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Nov 12, 2014 after 153 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 K091976 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091976: Biomet Phoenix Ankle Nail and Ankle Arthrodesis Nail, Biomet Trauma (2009) Summary page 5.

## Indications for use
The Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (malunited tibial pilon fracture) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis

Source page: https://510kreport.com/device/K141571
Methodology: https://510kreport.com/methodology