Cleared Traditional

K982040 - MEDPOR SURGICAL GRANULE IMPLANTS

K982040 is an FDA 510(k) clearance for MEDPOR SURGICAL GRANULE IMPLANTS, manufactured by Porex Surgical, Inc.. The device is a Class 2 Neurology device with product code GXP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982040 · Porex Surgical, Inc. · Neurology device
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Sep 1998
Decision
90d
Days
Class 2
Risk

K982040 is an FDA 510(k) clearance for the MEDPOR SURGICAL GRANULE IMPLANTS. Classified as Methyl Methacrylate For Cranioplasty (product code GXP), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (College Park, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5300 - 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 - K982040

510(k) Number K982040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1998
Decision Date September 08, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXP Device Classification - Class 2, Special Controls

Product Code GXP Methyl Methacrylate For Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5300
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.