# K040500: Arthrotek Lactonail

- Pathway: 510(k) (Traditional)
- Applicant: Arthrotek, Inc.
- Decided: May 25, 2004 after 89 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: 1 generation back to K925098 (1994). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925098: Biofix Absorbable Self-Reinforced Poly-L-Lactide, Bioscience, Inc. (1994) Summary page 1.

## Most influential descendants
- K043339: Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG (2005), 1 descendant of its own
- K151876: Bio2 Fusion Implant System (2015), 0 descendants of its own

## Indications for use
The Arthrotek® LactoNail is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies, and arthrodesis. Examples include the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

Source page: https://510kreport.com/device/K040500
Methodology: https://510kreport.com/methodology