Cleared Traditional

K151285 - VSP Cranial System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151285 · 3D Systems, Inc. · Neurology device
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Sep 2016
Decision
498d
Days
Class 2
Risk

K151285 is an FDA 510(k) clearance for the VSP Cranial System. Classified as Cranial Surgical Planning And Instrument Guides (product code PPT), Class II - Special Controls.

Submitted by 3D Systems, Inc. (Golden, US). The FDA issued a Cleared decision on September 23, 2016 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all 3D Systems, Inc. devices

Submission Details

510(k) Number K151285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2015
Decision Date September 23, 2016
Days to Decision 498 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
350d slower than avg
Panel avg: 148d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PPT Cranial Surgical Planning And Instrument Guides
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
Definition Software And Hardware For Surgical Planning To Create Patient-specific Anatomical Models, Surgical Templates, And Guides For Use In The Marking Or Cutting Of Cranial Bone For Neurosurgical Procedures.
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 Neurology devices follow this clearance model.

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