# K150463: CalcaNail Orthopedic Nail

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: May 22, 2015 after 88 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: 4 generations back to K982953 (1998). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 5.
- K070617: Cannulated Screw, Fournitures Hospitalieres Industrie (2007) Summary page 5.
- K091788: Panta Nail (Dia. 10MM), Panta Nail XL, Newdeal Sas (2009) Summary page 5.

## Indications for use
The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

Source page: https://510kreport.com/device/K150463
Methodology: https://510kreport.com/methodology