Cleared Traditional

K251714 - Ion-C

K251714 · SurGenTec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
227d
Days
-
Risk

K251714 is an FDA 510(k) clearance for the Ion-C. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on January 16, 2026 after a review of 227 days - an extended review cycle.

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 SurGenTec, LLC devices

FDA 510(k) Submission Details - K251714

510(k) Number K251714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2025
Decision Date January 16, 2026
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 68
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K251714.
Ion-L
K261209 · SurGenTec, LLC · Jun 2026
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K253676 · Providence Medical Technology, Inc. · May 2026
DiversiVy™ Facet Screw System
K253432 · Vy Spine, LLC · Mar 2026
FFX Facet Fixation System
K250679 · Sc Medica · Dec 2025
CORUS-LX Implant
K253190 · Providence Medical Technology, Inc. · Nov 2025
FFX Facet Fixation System
K252153 · Sc Medica · Oct 2025