# K181086: Cortical Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cousin Biotech Sas
- Decided: Jan 9, 2019 after 259 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: 7 generations back to K792022 (1979). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 4.
- K100652: Acl Tightrope, Arthrex, Inc. (2010) Summary page 4.
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 4.

## Indications for use
The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

Source page: https://510kreport.com/device/K181086
Methodology: https://510kreport.com/methodology