# K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 13, 2005 after 71 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). 39 ancestors in all.
217 later devices descend from it; 15 cite it directly.
0 of 257 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 1.
- K023294: Bosworth Coraco-Clavicular Screw, Howmedica Osteonics Corp. (2002) Summary page 1.
- K041356: Arthrex Tenodesis Screw Family, Arthrex, Inc. (2004) Summary page 1.
- K003227: Bio-Absorbable Corkscrew Model AR-1920B, Arthrex, Inc. (2001) Summary page 1.
- (no number) Kirschner (K)Wire: named in the summary without a submission number

## Most influential descendants
- 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
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor (2011), 49 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own

## Indications for use
The TightRope TM Acromioclavicular (AC) 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 Acromioclavicular (AC) Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Source page: https://510kreport.com/device/K052776
Methodology: https://510kreport.com/methodology