# K213530: Nextra CH Cannulated Hammertoe System

- Pathway: 510(k) (Special)
- Applicant: Nextremity Solutions, Inc.
- Decided: Dec 9, 2021 after 34 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K013888 (2002). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200840: DuoHex CH Cannulated Hammertoe System, Nextremity Solutions, Inc. (2020) Summary page 4.

## Most influential descendants
- K221610: Nextra CH Cannulated Hammertoe System (2022), 0 descendants of its own

## Recalls of this device
- Jan 13, 2022 · Class II · Z-0739-2022: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, re
- Jan 13, 2022 · Class II · Z-0740-2022: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, re

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

Source page: https://510kreport.com/device/K213530
Methodology: https://510kreport.com/methodology