# K061925: Mini Tightrope Repair Kit, Model AR-8911DS

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 31, 2006 after 116 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: 7 generations back to K792022 (1979). 41 ancestors in all.
33 later devices descend from it; 11 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041189: Arthrex Trimit Family, Arthrex, Inc. (2004) Summary page 1.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 1.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K071978: Mini Tightrope FT Repair Kit (2007), 22 descendants of its own
- K090107: Mini Tightrope (2009), 21 descendants of its own
- K133275: Mini Tightrope (2014), 11 descendants of its own
- K140328: CMC Mini Tightrope (2014), 6 descendants of its own
- K141420: Fastforward (2014), 5 descendants of its own

## Indications for use
The Mini TightRopeTM Repair Kit 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 Mini TightRopeT M Repair Kit is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of l1t metatarsal - 2 nd metatarsal intermetatarsal angle.

Source page: https://510kreport.com/device/K061925
Methodology: https://510kreport.com/methodology