Cleared Traditional

K012350 - MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

K012350 is an FDA 510(k) clearance for MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL, manufactured by Porex Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K012350 · Porex Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
232d
Days
Class 2
Risk

K012350 is an FDA 510(k) clearance for the MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (Newnan, US). The FDA issued a Cleared decision on March 14, 2002 after a review of 232 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Porex Surgical, Inc. devices

FDA 510(k) Submission Details - K012350

510(k) Number K012350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date March 14, 2002
Days to Decision 232 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FWP Prosthesis, Chin, Internal

All 28
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K012350.
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IMPLANTECH TEMPORAL IMPLANT
K943644 · Implantech Associates, Inc. · Oct 1994
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K933367 · W.L. Gore & Associates, Inc. · Jul 1994