# K212990: Acumed Ankle Syndesmosis Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jan 7, 2022 after 109 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: 9 generations back to K792022 (1979). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 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.
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor, Acumed, LLC (2011) Summary page 4.
- K133469: Acumed Suture Anchor System, Acumed, LLC (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K212990
Methodology: https://510kreport.com/methodology