# K162805: Akros Fibulink Syndesmosis Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Akros Medical
- Decided: Jan 10, 2017 after 97 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: 6 generations back to K792022 (1979). 36 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 4.

## Most influential descendants
- K173550: Akros FibuLink™ Syndesmosis Repair Kit (2017), 4 descendants of its own
- K211770: R3ACT Stabilization System (2021), 3 descendants of its own
- K223589: Grappler Suture Anchor R3FLEX IOL System (2023), 2 descendants of its own
- K240594: Grappler Suture Anchor R3FLEX IOL System (2024), 1 descendant of its own
- K253886: Grappler Suture Anchor PCFD Tether System (2026), 0 descendants of its own

## Indications for use
The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K162805
Methodology: https://510kreport.com/methodology