# K220650: TriMed Ripcord Device

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jun 1, 2022 after 86 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904436 (1990). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 4.
- K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, Arthrex, Inc. (2020) Summary page 4.

## Most influential descendants
- K251134: RipCord (2025), 0 descendants of its own

## Recalls of this device
- Dec 22, 2022 · Class II · Z-1101-2023: Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

## 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/K220650
Methodology: https://510kreport.com/methodology