# K191053: Xtreme-Loop

- Pathway: 510(k) (Traditional)
- Applicant: Xiros, Ltd.
- Decided: Jul 17, 2019 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: 3 generations back to K922559 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151601: Secure-Loop, Xiros, Ltd. (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K191053
Methodology: https://510kreport.com/methodology