Cleared Special

Infinity™ OCT System and PASS OCT Spinal System (K220810) - FDA 510(k) Clearance

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

K220810 · Medicrea International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
29d
Days
Class 2
Risk

K220810 is an FDA 510(k) clearance for the Infinity™ OCT System and PASS OCT Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medicrea International (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on April 19, 2022 after a review of 29 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 Medicrea International devices

Submission Details

510(k) Number K220810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2022
Decision Date April 19, 2022
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 81
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K220810.
NuVasive Reline Cervical System
K221388 · Nu Vasive, Incorporated · Sep 2022
Ennovate Cervical Spinal and Occiput System
K213871 · Aesculap Implant Systems, LLC · Jul 2022
M.U.S.T. MINI Posterior Cervical Screws System Extension
K220570 · Medacta International S.A. · Apr 2022
NuVasive Reline Cervical System
K213654 · Nu Vasive, Incorporated · Feb 2022
Vy Spine™ VySpan™ PCT System
K213394 · Vy Spine, LLC · Dec 2021
Altus Spine Sochi OCT Spinal System
K210887 · Altus Partners, LLC · Aug 2021