# K141004: Intraosseous Fixation System

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Aug 21, 2014 after 125 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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 K954385 (1996). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120165: Intraosseous Fixation System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 4.
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology, Orthohelix Surgical Designs, Inc. (2010) Summary page 4.
- K133636: Extremity Medical Hammertoe Device, Extremity Medical, LLC (2014) Summary page 4.
- K061164: Activapin, Bioretec, Ltd. (2006) Summary page 4.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

Source page: https://510kreport.com/device/K141004
Methodology: https://510kreport.com/methodology