Cleared Special

Infinity? OCT System

K254165 · Medtronic Sofamor Danek USA, Inc. · Orthopedic

Jan 2026

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K254165 is an FDA 510(k) clearance for the Infinity? OCT System, a Posterior Cervical Screw System (Class II — Special Controls, product code NKG), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on January 21, 2026, 30 days after receiving the submission on December 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number	K254165 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NKG — Posterior Cervical Screw System
Device Class	Class II — 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.