# K151601: Secure-Loop

- Pathway: 510(k) (Traditional)
- Applicant: Xiros, Ltd.
- Decided: Sep 9, 2015 after 89 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: 2 generations back to K922559 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K191053: Xtreme-Loop (2019), 0 descendants of its own

## Indications for use
The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

Source page: https://510kreport.com/device/K151601
Methodology: https://510kreport.com/methodology