Cleared Special

K232167 - VySpan PCT System

K232167 is the FDA 510(k) clearance for VySpan PCT System by Vy Spine, LLC. It is a Class 2 Orthopedic device (product code NKG) cleared through the Special 510(k) pathway after a 68-day FDA review.

K232167 · Vy Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
68d
Days
Class 2
Risk

K232167 is an FDA 510(k) clearance for the VySpan™ PCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on September 27, 2023 after a review of 68 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 Vy Spine, LLC devices

Submission Details

510(k) Number K232167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2023
Decision Date September 27, 2023
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K232167.
Statera-C™ Spinal System
K233332 · K&J Consulting Corp. · Nov 2023
Posterior Cervical Spine System
K233078 · Double Medical Technology, Inc. · Nov 2023
SYMPHONY OCT System
K233366 · Medos International SARL · Nov 2023
NorthStar OCT System
K231654 · Seaspine, Inc. · Aug 2023
CastleLoc-S Posterior Cervical Fixation System
K231840 · L & K Biomed Co., Ltd. · Jul 2023
Edge Upper Cervical System
K221307 · Spinal Simplicity, LLC · Jul 2023