# K113006: I-Fuse Hammer Toe Systems

- Pathway: 510(k) (Traditional)
- Applicant: Orthopro, LLC
- Decided: May 25, 2012 after 231 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: 2 generations back to K960385 (1996). 4 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990804: Stayfuse, Pioneer Surgical Technology (1999) Summary page 1.
- K070555: Orthopro Steinman Pins and Kirschner Wires, Orthopro, LLC (2007) Summary page 1.

## Most influential descendants
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own
- K181872: MIS Bunion System (2019), 14 descendants of its own
- K142585: PhaLinx Hammertoe System (2014), 9 descendants of its own
- K221181: Treace Medical Concepts (TMC) Plating System (2023), 7 descendants of its own

## Indications for use
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Source page: https://510kreport.com/device/K113006
Methodology: https://510kreport.com/methodology