# K162685: 2-Piece Hammertoe Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Jun 9, 2017 after 256 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: 8 generations back to K915818 (1992). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130859: Hammertoe Correction System, Arthrosurface, Inc. (2013) Summary page 4.
- K153065: The Hammertoe Correction System, Life Spine, Inc. (2016) Summary page 4.
- K142585: PhaLinx Hammertoe System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 4.
- K142478: opti-Toe, Graham Medical Technologies, LLC (D.B.A.Gramedica) (2015) Summary page 4.
- K990804: Stayfuse, Pioneer Surgical Technology (1999) Summary page 4.
- K022726: Stayfuse GT-IP, Pioneer Surgical Technology (2002) Summary page 4.

## Indications for use
The 2-Piece 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/K162685
Methodology: https://510kreport.com/methodology