# K220260: Hercules Syndesmosis Implant System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Mar 31, 2022 after 59 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: 12 generations back to K792022 (1979). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 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 5.
- K170249: GRAVITY™ Syndesmosis LP, Wrightmedicaltechnologyinc (2017) Summary page 5.
- K170440: KISSloc Suture System, Arthrosurface, Inc. (2017) Summary page 5.

## Indications for use
The Hercules® Syndesmosis Implant 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 B and C ankle fractures and as an adjunct in external and intramedullary fixation systems. The Hercules® Syndesmosis Implant System is also intended to provide fixation during healing process after joint reconstruction in the midfoot and forefoot including correction of hallux valgus deformity.

Source page: https://510kreport.com/device/K220260
Methodology: https://510kreport.com/methodology