# K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 16, 2005 after 85 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: 5 generations back to K792022 (1979). 35 ancestors in all.
306 later devices descend from it; 26 cite it directly.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033717: Transet Fracture Fixation System, Bonutti Research, Inc. (2004) Summary page 1.
- K963172: Synthes Sterile 4.5 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K003077: Smartscrew Model 222006...227510, Bionx Implants, Ltd. (2001) Summary page 1.
- K030900: Inion Otps Biodegradable Fixaton System, Inion, Ltd. (2003) Summary page 1.
- K984550: Pre-Threaded Endobutton, Smith & Nephew, Inc. (1999) Summary page 1.
- (no number) Kirschner (K)Wire (Synthes): named in the summary without a submission number

## Most influential descendants
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K083070: Toggleloc System (2008), 94 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device (2008), 59 descendants of its own

## Indications for use
The Arthrex TightRopeTM Syndesmosis Device 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 TightRope TM Syndesmosis Device 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/K043248
Methodology: https://510kreport.com/methodology