Cleared Traditional

K922489 - MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA

K922489 is an FDA 510(k) clearance for MEDPOR SURG IMPLANT MATERIAL:PREFOR CRA..., manufactured by Porex Technologies Corp.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K922489 · Porex Technologies Corp. · General & Plastic Surgery device
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Sep 1992
Decision
98d
Days
Class 2
Risk

K922489 is an FDA 510(k) clearance for the MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Porex Technologies Corp. (Fairburn, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 98 days - within the typical 510(k) review window.

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 Technologies Corp. devices

FDA 510(k) Submission Details - K922489

510(k) Number K922489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 02, 1992
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 45
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K922489.
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K.D. CHIN IMPLANT
K914297 · Implantech Associates, Inc. · Dec 1991
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K913761 · Implantech Associates, Inc. · Oct 1991