# K112990: Acl Tightrope,Acl Tightrope Duuble Bundle

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 19, 2011 after 74 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: 7 generations back to K904436 (1990). 27 ancestors in all.
49 later devices descend from it; 10 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100652: Acl Tightrope, Arthrex, Inc. (2010)

## Cited in the summary but kept off the family tree
- K101837: Acl Tightrope Double Bundle, Arthrex, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K101123: Nexfin Model 2, Bmeye B.V. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 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
- K231857: Arthrex TightRope II (2023), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 descendants of its own

## Indications for use
The ACL TightRope and ACL TightRope Double Bundle are 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 for ACL/PCL repair and reconstruction.

Source page: https://510kreport.com/device/K112990
Methodology: https://510kreport.com/methodology