Cleared Special

K210449 - Infinity™ OCT System, PASS OCT® Spinal System

K210449 is an FDA 510(k) clearance for Infinity OCT System, manufactured by Medtronic. The device is a Class 2 Orthopedic device with product code NKG cleared through the Special 510(k) pathway after a 30-day FDA review.

K210449 · Medtronic · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
30d
Days
Class 2
Risk

K210449 is an FDA 510(k) clearance for the Infinity™ OCT System, PASS OCT® Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medtronic (Memphis, US). The FDA issued a Cleared decision on March 18, 2021 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.

FDA 510(k) Submission Details - K210449

510(k) Number K210449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2021
Decision Date March 18, 2021
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.

NKG Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K210449.
QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K211957 · Globus Medical, Inc. · Aug 2021
Z-LINKPC System
K211993 · Zavation Medical Products, LLC · Aug 2021
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
K211710 · Orthofix, Inc. · Jul 2021
SYMPHONY™ OCT System
K203319 · Medos International SARL · Feb 2021
Invictus™ OCT Spinal Fixation System
K203125 · Alphatec Spine, Inc. · Dec 2020
M.U.S.T. MINI Posterior Cervical Screws System
K203149 · Medacta International S.A. · Nov 2020
K210449 · Infinity™ OCT System, PASS OCT® Spinal System
Download PDF FDA Summary Medtronic