Cleared Traditional

K252153 - FFX Facet Fixation System (FDA 510(k) Clearance)

K252153 · Sc Medica · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
99d
Days
-
Risk

K252153 is an FDA 510(k) clearance for the FFX Facet Fixation System. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Sc Medica (Strasbourg, FR). The FDA issued a Cleared decision on October 16, 2025 after a review of 99 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 Sc Medica devices

Submission Details

510(k) Number K252153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2025
Decision Date October 16, 2025
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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
NCT05645497 Unknown Observational Industry-sponsored

Evaluation of the Efficacy and Safety of the FACET FIXation Implant.

Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.

116
Patients (est.)
1
Site
Condition studied Degenerative Lumbar Spinal Stenosis
Eligibility All sexes · 18 Years+
Sponsor SC Medica (industry)
Started 2023-01-17 → Primary completion 2023-04-30
Primary outcome
The rate of fusion
View full study on ClinicalTrials.gov

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 75
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K252153.
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
Ion-C
K251714 · SurGenTec, LLC · Jan 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
K251885 · Providence Medical Technology, Inc. · Jul 2025
Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025