# K202581: Arthrex TightRope II

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 4, 2020 after 57 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: 8 generations back to K904436 (1990). 28 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 38 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 4.

## Most influential descendants
- K221128: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (2022), 6 descendants of its own
- K231857: Arthrex TightRope II (2023), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 descendants of its own
- K253693: Strut Suture; No-Tie Button (2026), 0 descendants of its own
- K260405: FiberTape Button (2026), 0 descendants of its own

## Indications for use
The Arthrex TightRope II is intended to be used for fixation of bone to bone or soft tissue to bone, and is 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.

Source page: https://510kreport.com/device/K202581
Methodology: https://510kreport.com/methodology