# K100652: Acl Tightrope

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jun 23, 2010 after 107 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 6 generations back to K904436 (1990). 26 ancestors in all.
65 later devices descend from it; 4 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062747: Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM, Arthrex, Inc. (2006) Summary page 1.
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS, Arthrex, Inc. (2003) Summary page 1.

## Most influential descendants
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle (2011), 49 descendants of its own
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 descendants of its own
- K122374: Arthrex Suture (Uhmwpe) (2012), 13 descendants of its own
- K202581: Arthrex TightRope II (2020), 9 descendants of its own
- K221128: Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (2022), 6 descendants of its own

## Indications for use
The ACL TightRope is 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 this for Anterior Cruciate Ligament (ACL) Repair.

Source page: https://510kreport.com/device/K100652
Methodology: https://510kreport.com/methodology