# K251134: RipCord

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jul 11, 2025 after 91 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: 10 generations back to K904436 (1990). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220650: TriMed Ripcord Device, TriMed, Inc. (2022) 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.

## Indications for use
TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities. The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.

Source page: https://510kreport.com/device/K251134
Methodology: https://510kreport.com/methodology