Cleared Special

K254165 - Infinity™ OCT System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K254165 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
30d
Days
Class 2
Risk

K254165 is an FDA 510(k) clearance for the Infinity™ OCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on January 21, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - the FDA orthopedic device regulatory framework. 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K254165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date January 21, 2026
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKG Posterior Cervical Screw System

All 116
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K254165.
CarboClear® Posterior Cervical Screw System
K254045 · CarboFix Orthopedics , Ltd. · Mar 2026
CMORE® CT System
K252327 · Icotec AG · Nov 2025
Infinity™ OCT System
K253129 · Medtronic Sofamor Danek USA, Inc. · Oct 2025
ANAX™ OCT Spinal System
K251725 · Cg Medtech Co., Ltd. · Jun 2025
Sovereign Posterior Cervical System
K250866 · Met One Technologies, LLC · May 2025
Freedom Posterior Cervical Screws
K242674 · Signature Orthopaedics Pty, Ltd. · May 2025