# K231857: Arthrex TightRope II

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 8, 2023 after 46 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: 10 generations back to K904436 (1990). 84 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 4.
- K221128: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II, Arthrex, Inc. (2022) Summary page 4.
- K202581: Arthrex TightRope II, Arthrex, Inc. (2020) Summary page 4.

## Most influential descendants
- K241235: Arthrex TightRope II (2024), 3 descendants of its own
- K260405: FiberTape Button (2026), 0 descendants of its own
- K250867: Dunamis Screw and Suture Locking System (2025), 0 descendants of its own
- K250424: Arthrex TightRope Soft Button, RT (2025), 0 descendants of its own

## Indications for use
The Arthrex TightRope II devices are 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 devices for ACL/PCL repair and reconstruction for the adult and pediatric patient population; and MCL, POL, LCL repair and reconstruction, IBT, and PRT for the adult population only.

Source page: https://510kreport.com/device/K231857
Methodology: https://510kreport.com/methodology