Cleared Special

K243265 - Ion 3D

K243265 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
50d
Days
-
Risk

K243265 is an FDA 510(k) clearance for the Ion 3D. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on December 4, 2024 after a review of 50 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.

FDA 510(k) Submission Details - K243265

510(k) Number K243265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2024
Decision Date December 04, 2024
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K243265.
Arthrex Spine Compression FT Screw
K250920 · Arthrex, Inc. · May 2025
The Karma® Fixation System
K242527 · Spinal Elements, Inc. · May 2025
AERO MIS Facet Fusion System
K243865 · Aurora Spine · Mar 2025
zLOCK Lumbar Facet Fixation System
K242650 · Zygofix , Ltd. · Sep 2024
PMT Posterior Cervical Stabilization System (PCSS)
K241035 · Providence Medical Technology, Inc. · Jun 2024
Ion 3D
K241416 · SurGenTec, LLC · Jun 2024
K243265 · Ion 3D
Download PDF FDA Summary SurGenTec, LLC