# K200840: DuoHex CH Cannulated Hammertoe System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Jun 26, 2020 after 87 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: 8 generations back to K013888 (2002). 27 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122031: Nextra TI Hammertoe Correction System, Nextremity Solutions, LLC (2012) Summary page 4.
- K110445: Flexfusion (TM) Fixation Implant, Nextremity Solutions, LLC (2011) Summary page 4.
- K150252: PHALINX Hammertoe System, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Most influential descendants
- K213530: Nextra CH Cannulated Hammertoe System (2021), 1 descendant of its own
- K221610: Nextra CH Cannulated Hammertoe System (2022), 0 descendants of its own
- K211996: Nexta PEEK Hammertoe Correction System (2021), 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 DuoHex™ 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/K200840
Methodology: https://510kreport.com/methodology