Cleared Traditional

K153336 - VuePoint OCT System

K153336 is the FDA 510(k) clearance for VuePoint OCT System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K153336 · Nu Vasive, Incorporated · Orthopedic device
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Jan 2016
Decision
49d
Days
Class 2
Risk

K153336 is an FDA 510(k) clearance for the VuePoint OCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on January 7, 2016 after a review of 49 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K153336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2015
Decision Date January 07, 2016
Days to Decision 49 days
Submission Type Traditional
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
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K153336.
Certex Spinal Fixation System
K160428 · X-Spine Systems, Inc. · May 2016
Zimmer Virage OCT Spinal Fixation System
K153631 · Zimmer Spine, Inc. · Feb 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · Spineart · Jan 2016
VERTEX(r) Reconstruction System
K152338 · Medtronic Sofamor Danek USA, Inc. · Oct 2015
NuVasive VuePoint II OCT System
K150474 · Nu Vasive, Incorporated · Oct 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · Spinal Elements, Inc. · Sep 2015