# K241235: Arthrex TightRope II

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: May 29, 2024 after 27 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: 15 generations back to K961555 (1996). 121 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231857: Arthrex TightRope II, Arthrex, Inc. (2023) Summary page 5.
- K232973: Arthrex Knee FiberTak® Button Suture Anchor, Arthrex, Inc. (2023) Summary page 5.
- K232742: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2023) Summary page 5.
- K231113: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2023) Summary page 5.

## Most influential descendants
- 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; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction.

Source page: https://510kreport.com/device/K241235
Methodology: https://510kreport.com/methodology