Cleared Special

K241416 - Ion 3D

K241416 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
31d
Days
-
Risk

K241416 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 June 17, 2024 after a review of 31 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 SurGenTec, LLC devices

Submission Details

510(k) Number K241416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date June 17, 2024
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 46
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K241416.
Ion 3D
K243265 · SurGenTec, LLC · Dec 2024
zLOCK Lumbar Facet Fixation System
K242650 · Zygofix , Ltd. · Sep 2024
PMT Posterior Cervical Stabilization System (PCSS)
K241035 · Providence Medical Technology, Inc. · Jun 2024
SC Medica FFX
K232468 · Sc Medica · May 2024
zLOCK Lumbar Facet Fixation System
K240085 · Zygofix , Ltd. · Apr 2024
Ion 3D
K240086 · SurGenTec, LLC · Feb 2024