# K231343: Redemption Duo Hindfoot Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Jan 30, 2024 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: 1 generation back to K091976 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 4.

## Most influential descendants
- K260900: DYNEX® External Fixation Systems (2026), 0 descendants of its own

## Indications for use
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion) Specific indications include: • Post-traumatic or degenerative arthritis • Previously infected arthrosis • Revision ankle arthrodesis • Failed total ankle arthroplasty • Avascular necrosis of the talus • Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease • Rheumatoid arthritis • Osteoarthritis • Pseudarthrosis • Trauma (malunited tibial pilon fracture) • Charcot foot • Severe endstage degenerative arthritis • Severe defects after tumor resection • Pantalar arthrodesis • Post-traumatic arthrosis • Neuroarthropathy

Source page: https://510kreport.com/device/K231343
Methodology: https://510kreport.com/methodology