# K140324: Rigidloop Adjustable Cortical Implant: Standard, Long and XL

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson and Johnson Company
- Decided: Jul 7, 2014 after 147 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: 9 generations back to K904436 (1990). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 1.
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 1.
- K123362: Milagro Advance Interference Screw, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 1.

## Indications for use
The RIGIDLOOP Adjustable Cortical Fixation System is indicated for fixation of soft tissue to bone in Femoral Cruciate Ligament Reconstruction.

Source page: https://510kreport.com/device/K140324
Methodology: https://510kreport.com/methodology