# K071978: Mini Tightrope FT Repair Kit

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Aug 15, 2007 after 28 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: 8 generations back to K792022 (1979). 42 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K133835: Arthrosurface Kissloc Knotless Suture System (2014), 2 descendants of its own
- K111032: CMC Cable Fix (2011), 2 descendants of its own

## Indications for use
The Mini TightRope FP Repair Kit is intended as an adjunct in firactuIre repair involving metaphyseal and periarticular small bone fragrnents 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 Mini TightRope FT Repair Kit is intended 1o provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsad distal radioul nar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hadlux Valgus reconstruction (conrection) by providing for tie reduction of It metatarsal -2I' metatarsal inteimetatarsal angle.

Source page: https://510kreport.com/device/K071978
Methodology: https://510kreport.com/methodology