# K082384: Hav-Lok Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Dec 8, 2008 after 111 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K792022 (1979). 42 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- K091763: Michelangelo Bunion System - Mabs, Model: MA6000 (2009), 4 descendants of its own
- K111032: CMC Cable Fix (2011), 2 descendants of its own
- K200332: EXPERT - Joint Fixation System (2020), 1 descendant of its own
- K242311: EXPERT - Flexible Joint Fixation System (2024), 0 descendants of its own
- K183094: CyclaPlex Correction System (2019), 0 descendants of its own

## Indications for use
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.

Source page: https://510kreport.com/device/K082384
Methodology: https://510kreport.com/methodology