# K163627: Shotel Ankle Arthrodesis Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Sep 14, 2017 after 266 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 K043583 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100925: Ascension Ankle Fusion Nail System, Ascension Orthopedics, Inc. (2010) Summary page 4.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K053394: Nexa Bone Screw System, Nexa Orthopedics, Inc. (2005) Summary page 4.

## Indications for use
The Shotel Ankle Arthrodesis Nail System is intended for the following: • Charcot Foot • Avascular necrosis of the talus • Failed total ankle arthroplasty • Trauma (malunited tibial pilon fracture) • Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease • Revision ankle arthrodesis • Neuroarthropathy • Rheumatoid arthritis • Osteoarthritis • Pseudoarthrosis • Post-Traumatic arthrosis • Previously infected arthrosis • Severe end stage degenerative arthritis • Severe defects after tumor resection • Pantalar arthrodesis

Source page: https://510kreport.com/device/K163627
Methodology: https://510kreport.com/methodology