Cleared Traditional

K101835 - MEDPOR FIXATION SYSTEM-CRANIAL

K101835 is an FDA 510(k) clearance for MEDPOR FIXATION SYSTEM-CRANIAL, manufactured by Porex Surgical, Inc.. The device is a Class 2 Neurology device with product code HBW cleared through the Traditional 510(k) pathway after a 155-day FDA review.

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

FDA 510(k) Submission Details - K101835

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.

HBW Device Classification - Class 2, Special Controls

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.