Cleared Traditional

K902285 - THE MAGNUM CHIN IMPLANT

K902285 is an FDA 510(k) clearance for THE MAGNUM CHIN IMPLANT, 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 113-day FDA review.

K902285 · Applied Biomaterial Technologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
113d
Days
Class 2
Risk

K902285 is an FDA 510(k) clearance for the THE MAGNUM CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Applied Biomaterial Technologies (Bremerton, US). The FDA issued a Cleared decision on September 12, 1990 after a review of 113 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 Applied Biomaterial Technologies devices

FDA 510(k) Submission Details - K902285

510(k) Number K902285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1990
Decision Date September 12, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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 K902285.
ZARA SOFT TIP CHIN IMPLANT
K910458 · Byron Medical · Feb 1991
FLOWERS CHIN IMPLANT
K905267 · Implantech Associates, Inc. · Jan 1991
FLOWERS JOWL IMPLANT
K905268 · Implantech Associates, Inc. · Jan 1991
CURVILINEAR SILICONE CHIN IMPLANT
K902941 · Implantech Associates, Inc. · Aug 1990
EXTENDED CHIN IMPLANT STYLE I
K902824 · Implantech Associates, Inc. · Aug 1990
EXTENDED CHIN IMPLANT STYLE II
K902825 · Implantech Associates, Inc. · Aug 1990