# K221128: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 5, 2022 after 170 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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: 9 generations back to K904436 (1990). 50 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202581: Arthrex TightRope II, Arthrex, Inc. (2020) Summary page 4.
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 4.
- K110123: PCL Tightrope, Arthrex, Inc. (2011) Summary page 4.

## Most influential descendants
- K231857: Arthrex TightRope II (2023), 4 descendants of its own
- 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 ACL TightRope®, PCL TightRope®, and 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.

Source page: https://510kreport.com/device/K221128
Methodology: https://510kreport.com/methodology