FFX Facet Fixation System

FDA 510(k) K252153 · Sc Medica

Substantially Equivalent

510(k) numberK252153

Submission

Device name
FFX Facet Fixation System
Applicant
Sc Medica
Strasbourg, FR
Received
July 9, 2025
Decision date
October 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRW – System, Facet Screw Spinal Device
Device class
Unclassified
Implant
Yes

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K253432DiversiVy™ Facet Screw SystemMRW · Traditional Vy Spine, LLC03/19/2026SE
K251714Ion-CMRW · Traditional SurGenTec, LLC01/16/2026SE
K250679FFX Facet Fixation SystemMRW · Traditional Sc Medica12/04/2025SE
K253190CORUS-LX ImplantMRW · Traditional Providence Medical Technology, Inc.11/20/2025SE
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special Providence Medical Technology, Inc.07/10/2025SE
K250920Arthrex Spine Compression FT ScrewMRW · Traditional Arthrex, Inc.05/22/2025SE
K242527The Karma® Fixation SystemMRW · Traditional Spinal Elements, Inc.05/21/2025SE
K243865AERO MIS Facet Fusion SystemMRW · Traditional Aurora Spine03/24/2025SE

More from Aurora Spine

510(k)DeviceDecision
K250679FFX Facet Fixation SystemMRW · Traditional 12/04/2025SE
K232468SC Medica FFXMRW · Traditional 05/09/2024SE

Questions and answers

When was FFX Facet Fixation System cleared by the FDA?

FFX Facet Fixation System (K252153) received a 510(k) decision of Substantially Equivalent on October 16, 2025, 99 days after the submission was received.

What is the product code of K252153?

The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.