Cleared Traditional

zLOCK Lumbar Facet Fixation System (K240085) - FDA 510(k) Clearance

K240085 · Zygofix , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
98d
Days
-
Risk

K240085 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 April 18, 2024 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Zygofix , Ltd. devices

Submission Details

510(k) Number K240085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2024
Decision Date April 18, 2024
Days to Decision 98 days
Submission Type Traditional
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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

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.

Clinical Evidence

ClinicalTrials.gov
NCT04229316 Completed Interventional Industry-sponsored

Safety And Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study

24
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Low Back Pain
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Hanna Levy, Dr
Sponsor ZygoFix (industry)
Started 2018-04-12 → Primary completion 2024-05-31
Primary outcome
Safety assessment - no device related reoperation
Secondary outcome
Efficacy assessment - achieving facet fusion 12 months post procedure
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K240085.
PMT Posterior Cervical Stabilization System (PCSS)
K241035 · Providence Medical Technology, Inc. · Jun 2024
Ion 3D
K241416 · SurGenTec, LLC · Jun 2024
SC Medica FFX
K232468 · Sc Medica · May 2024
Ion 3D
K240086 · SurGenTec, LLC · Feb 2024
PMT Facet Fixation System, Lumbar (PMT FFS-LX)
K230840 · Providence Medical Technology, Inc. · Dec 2023
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System
K232877 · K&J Consulting Corporation · Dec 2023