# K221031: Arthrex DualCompression Hindfoot Fusion Nail Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 20, 2022 after 257 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: 5 generations back to K974781 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090857: Valor Ankle Fusion Nail System, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K142602: VALOR Hindfoot Fusion Nail System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K171376: DynaNail TTC Fusion System, MedShape, Inc. (2017) Summary page 4.
- K113828: Dynanail Ankle Arthrodesis Nail, MedShape, Inc. (2012) Summary page 4.

## Indications for use
The Arthrex DualCompression Hindfoot Fusion Nail Implant System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include neuro-osteoarthropathy (Charcot's Foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.

Source page: https://510kreport.com/device/K221031
Methodology: https://510kreport.com/methodology