# K090107: Mini Tightrope

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 6, 2009 after 203 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: 9 generations back to K792022 (1979). 55 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 77 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.
- K071978: Mini Tightrope FT Repair Kit, Arthrex, Inc. (2007) Summary page 1.
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS, Arthrex, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K241995: HyperFlex™ Bunion Correction System (2024), 1 descendant of its own

## Indications for use
The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; 2) Tarsometatarsal (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 1 st metatarsal -2nd metatarsal intermetatarsal angle. The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Source page: https://510kreport.com/device/K090107
Methodology: https://510kreport.com/methodology