# K130814: Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Aug 1, 2013 after 129 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 K792022 (1979). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 63 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 1.
- K081098: Endobutton Continuous Loop (CL), Smith & Nephew Inc., Endoscopy Division (2008) Summary page 1.
- K060664: Fastin RC Anchor, Depuy Mitek (2006) Summary page 1.
- K040004: Orthocord Suture, Depuy Mitek (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K042398: Orthocord suture. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K232941: Megaloop Button System (2024), 0 descendants of its own
- K232886: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (2023), 0 descendants of its own
- K202291: Button Loop (2021), 0 descendants of its own

## Indications for use
The RIGIDLOOPTM Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

Source page: https://510kreport.com/device/K130814
Methodology: https://510kreport.com/methodology