# K213644: Arthrex Knotless Mini TightRopes

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 17, 2021 after 29 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: 11 generations back to K792022 (1979). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133275: Mini Tightrope, Arthrex, Inc. (2014) Summary page 4.
- K061925: Mini Tightrope Repair Kit, Model AR-8911DS, Arthrex, Inc. (2006) Summary page 4.
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 4.

## Most influential descendants
- K240947: TENSOR®  Suture Button System (2024), 0 descendants of its own

## Indications for use
The Arthrex Knotless Mini TightRopes are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct to external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Knotless Mini TightRopes are 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 1st metatarsal -2nd metatarsal intermetatarsal angle. The Arthrex Knotless Mini TightRopes, 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 Knotless Mini TightRopes 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 metacarpal when the trapezium has been excised due to osteoarthritis. The Arthrex Knotless Mini TightRopes 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/K213644
Methodology: https://510kreport.com/methodology