# K250424: Arthrex TightRope Soft Button, RT

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 11, 2025 after 25 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K961555 (1996). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 5.
- K241235: Arthrex TightRope II, Arthrex, Inc. (2024) Summary page 5.

## Indications for use
The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; 1TB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

Source page: https://510kreport.com/device/K250424
Methodology: https://510kreport.com/methodology