# K122031: Nextra TI Hammertoe Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, LLC
- Decided: Oct 9, 2012 after 90 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: 4 generations back to K960385 (1996). 8 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110445: Flexfusion (TM) Fixation Implant, Nextremity Solutions, LLC (2011) Summary page 1.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K200840: DuoHex CH Cannulated Hammertoe System (2020), 3 descendants of its own
- K213530: Nextra CH Cannulated Hammertoe System (2021), 1 descendant of its own
- K142478: opti-Toe (2015), 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

## Indications for use
The Nextraim Ti Hammertoe Correction System is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.

Source page: https://510kreport.com/device/K122031
Methodology: https://510kreport.com/methodology