# K253618: QuadLock™ Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Abanza Tecnomed S.L
- Decided: Jan 6, 2026 after 49 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: 13 generations back to K792022 (1979). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243712: WasherCap™ Mini Fixation System (Model 45), Abanza Tecnomed S.L (2025) Summary page 5.

## Indications for use
The Quadlock ™ Fixation System is intended for fixation of suture/tape (soft tissue) to bone during surgical procedures, in skeletally mature pediatric and adult patients for the following indications for use: • Knee: - ACL/PCL Repair: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger. - ACL Reconstruction: using non-absorbable UHMWPE USP #2 sutures or larger, or non-absorbable UHMWPE 1.4mm tapes or larger.

Source page: https://510kreport.com/device/K253618
Methodology: https://510kreport.com/methodology