Cleared Traditional

OsteoFab Patient Specific Cranial Device (K180064) - FDA 510(k) Clearance

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

K180064 · Oxford Performance Materials, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
199d
Days
Class 2
Risk

K180064 is an FDA 510(k) clearance for the OsteoFab Patient Specific Cranial Device. Classified as Plate, Cranioplasty, Preformed, Non-alterable (product code GXN), Class II - Special Controls.

Submitted by Oxford Performance Materials, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 27, 2018 after a review of 199 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxford Performance Materials, Inc. devices

Submission Details

510(k) Number K180064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date July 27, 2018
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 148d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXN Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
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.

Regulatory Peers - GXN Plate, Cranioplasty, Preformed, Non-alterable

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