QuadLock™ Fixation System

FDA 510(k) K253618 · Abanza Tecnomed S.L

Substantially Equivalent

510(k) numberK253618

Submission

Device name
QuadLock™ Fixation System
Applicant
Abanza Tecnomed S.L
Mutilva, ES
Received
November 18, 2025
Decision date
January 6, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MBI – Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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K261632Thunderbolt SystemMBI · Special Responsive Arthroscopy, Inc.07/20/2026SE
K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special Smith & Nephew, Inc.07/09/2026SE
K260018Arthrex FiberButtonMBI · Traditional Arthrex, Inc.06/26/2026SE
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More from ZheJiang Decans Medical Devices Co., Ltd.

510(k)DeviceDecision
K250238WasherCap™ Fixation SystemMBI · Special 02/25/2025SE
K243712WasherCap™ Mini Fixation System (Model 45)MBI · Traditional 01/30/2025SE
K212197WasherCap Fixation SystemMBI · Traditional 09/22/2022SE

Questions and answers

When was QuadLock™ Fixation System cleared by the FDA?

QuadLock™ Fixation System (K253618) received a 510(k) decision of Substantially Equivalent on January 6, 2026, 49 days after the submission was received.

What is the product code of K253618?

The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.