# K151876: Bio2 Fusion Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bio2 Technologies, Inc.
- Decided: Dec 30, 2015 after 174 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 K960978 (1996). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 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.
- K142463: Bio2 CLM BG Bioactive Scaffold, Bio2 Technologies, Inc. (2014) Summary page 4.
- K043339: Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG, Xtremi-T, LLC (2005) Summary page 4.
- K142585: PhaLinx Hammertoe System, Wrightmedicaltechnologyinc (2014) Summary page 4.

## Indications for use
The Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization. When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.

Source page: https://510kreport.com/device/K151876
Methodology: https://510kreport.com/methodology