Cleared Traditional

K931500 - THE PERMARIDGE MATRIX CHIN

K931500 is an FDA 510(k) clearance for THE PERMARIDGE MATRIX CHIN, manufactured by Applied Biomaterial Technologies. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 602-day FDA review.

K931500 · Applied Biomaterial Technologies · General & Plastic Surgery device
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Nov 1994
Decision
602d
Days
Class 2
Risk

K931500 is an FDA 510(k) clearance for the THE PERMARIDGE MATRIX CHIN. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Applied Biomaterial Technologies (Silverdale, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 602 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Applied Biomaterial Technologies devices

FDA 510(k) Submission Details - K931500

510(k) Number K931500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date November 17, 1994
Days to Decision 602 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
487d slower than avg
Panel avg: 115d · This submission: 602d
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 49
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K931500.
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IMPLANTECH TEMPORAL IMPLANT
K943644 · Implantech Associates, Inc. · Oct 1994
GORE-TEX FACIAL IMPLANT
K933367 · W.L. Gore & Associates, Inc. · Jul 1994
GORETEX SAM FACIAL IMPLANT
K942280 · W.L. Gore & Associates, Inc. · Jul 1994