# K233531: OIC FLEX-FIX™ System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Implant Company
- Decided: Feb 2, 2024 after 92 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 K904436 (1990). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162996: INVISIKNOT Ankle Syndesmosis Repair Kit, Smith & Nephew, Inc. (2017) Summary page 5.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 5.
- K202971: DRPx Locking Distal Radius Plate System, Orthopaedic Implant Company (2021) Summary page 5.

## Indications for use
The OIC FLEX-FIX System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

Source page: https://510kreport.com/device/K233531
Methodology: https://510kreport.com/methodology