# K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 3, 2020 after 87 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: 6 generations back to K792022 (1979). 36 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 44 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.

## Most influential descendants
- K240035: TACTIX Vector Syndesmosis System (2024), 1 descendant of its own
- K220650: TriMed Ripcord Device (2022), 1 descendant of its own
- K252196: Arthrex FibuLock Nail System (2026), 0 descendants of its own
- K253727: Syndesmosis TightRope PRO (2025), 0 descendants of its own
- K251134: RipCord (2025), 0 descendants of its own

## Indications for use
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant 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 Arthrex Syndesmosis TightRope XP Buttress Plate 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.

Source page: https://510kreport.com/device/K201522
Methodology: https://510kreport.com/methodology