# K221610: Nextra CH Cannulated Hammertoe System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Nov 4, 2022 after 154 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K013888 (2002). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213530: Nextra CH Cannulated Hammertoe System, Nextremity Solutions, Inc. (2021) Summary page 4.

## Indications for use
The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

Source page: https://510kreport.com/device/K221610
Methodology: https://510kreport.com/methodology