Cleared Special

zLOCK Lumbar Facet Fixation System (K242650) - FDA 510(k) Clearance

K242650 · Zygofix , Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2024
Decision
16d
Days
-
Risk

K242650 is an FDA 510(k) clearance for the zLOCK Lumbar Facet Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Zygofix , Ltd. (Misgav, IL). The FDA issued a Cleared decision on September 20, 2024 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zygofix , Ltd. devices

Submission Details

510(k) Number K242650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2024
Decision Date September 20, 2024
Days to Decision 16 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Consultant

Mcra, LLC
Justin Eggleton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 31
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K242650.
The Karma® Fixation System
K242527 · Spinal Elements, Inc. · May 2025
AERO MIS Facet Fusion System
K243865 · Aurora Spine · Mar 2025
Ion 3D
K243265 · SurGenTec, LLC · Dec 2024
PMT Posterior Cervical Stabilization System (PCSS)
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Ion 3D
K241416 · SurGenTec, LLC · Jun 2024
SC Medica FFX
K232468 · Sc Medica · May 2024