# K190774: RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Jul 25, 2019 after 121 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 K971358 (1997). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button, Arthrex, Inc. (2012) Summary page 6.
- K173845: Arthrex SwiveLock, Arthrex, Inc. (2018) Summary page 6.

## Most influential descendants
- K232941: Megaloop Button System (2024), 0 descendants of its own

## Indications for use
The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture: Shoulder: Acromioclavicular repair Pectoralis major / minor repair(1) Biceps tenodesis Elbow: Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment Knee: Cruciate ligament reconstruction (1) Extracapsular repair: MCL, LCL, and Posterior oblique ligament Patellar tendon repair Meniscal root repair(2) (1) PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction (2) Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair. RIGIDLOOP™ Cortical Fixation System XL Implant When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopaedic procedures such as ACL repairs. When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications: Shoulder: Pectoralis major / minor repair Biceps tenodesis Elbow: Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment Knee: Cruciate ligament reconstruction Extracapsular repair: MCL, LCL, and Posterior oblique ligament Patellar tendon repair Meniscal root repair

Source page: https://510kreport.com/device/K190774
Methodology: https://510kreport.com/methodology