# K133275: Mini Tightrope

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 30, 2014 after 98 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: 10 generations back to K792022 (1979). 56 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 1.

## Most influential descendants
- K140328: CMC Mini Tightrope (2014), 6 descendants of its own
- K213644: Arthrex Knotless Mini TightRopes (2021), 1 descendant of its own
- K143092: Tensyn Plug (2015), 1 descendant of its own
- K141219: Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits (2014), 1 descendant of its own
- K243624: Acu-Sinch Knotless Mini (2025), 0 descendants 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 bane 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) Syndesmotlc trauma, such as fixation of dorsal distal radioulnar ligament (ORUL) disruptions; 2) Tarsometatarsal (TMVT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Mldfoot Reconstruction); and, 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st 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, distri6utlon 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 thumb metacarpal by providing stabilization between the base of the first and second metacarpals when the trapezium has been excised due to osteoarthritis. The Mini TightRope and Mini Tight Rope FT are also indicated for use as adjuncts in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Source page: https://510kreport.com/device/K133275
Methodology: https://510kreport.com/methodology