Cleared Traditional

K180064 - OsteoFab Patient Specific Cranial Device

K180064 is an FDA 510(k) clearance for OsteoFab Patient Specific Cranial Device, manufactured by Oxford Performance Materials, Inc.. The device is a Class 2 Neurology device with product code GXN cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K180064 · Oxford Performance Materials, Inc. · Neurology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K180064

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.

GXN Device Classification - Class 2, Special Controls

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

All 54
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