# K153065: The Hammertoe Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Aug 1, 2016 after 284 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: 7 generations back to K915818 (1992). 32 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 4.
- K150126: Life Spine Cannulated Screws, Life Spine, Inc. (2015) Summary page 4.

## Most influential descendants
- K171448: Hammertoe Correction System (2017), 0 descendants of its own
- K162685: 2-Piece Hammertoe Correction System (2017), 0 descendants of its own

## Indications for use
The Life Spine 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/K153065
Methodology: https://510kreport.com/methodology