Cleared Traditional

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (K101835) - FDA 510(k) Clearance

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

K101835 · Porex Surgical, Inc. · Neurology device
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Dec 2010
Decision
155d
Days
Class 2
Risk

K101835 is an FDA 510(k) clearance for the MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079. Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on December 3, 2010 after a review of 155 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5360 - 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 Porex Surgical, Inc. devices

Submission Details

510(k) Number K101835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2010
Decision Date December 03, 2010
Days to Decision 155 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
7d slower than avg
Panel avg: 148d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBW Fastener, Plate, Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5360
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.