Cleared Traditional

K902941 - CURVILINEAR SILICONE CHIN IMPLANT

K902941 is the FDA 510(k) clearance for CURVILINEAR SILICONE CHIN IMPLANT by Implantech Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FWP) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K902941 · Implantech Associates, Inc. · General & Plastic Surgery device
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Aug 1990
Decision
30d
Days
Class 2
Risk

K902941 is an FDA 510(k) clearance for the CURVILINEAR SILICONE CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on August 2, 1990 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Implantech Associates, Inc. devices

Submission Details

510(k) Number K902941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date August 02, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K902941.
HIGH PROFILE CHIN IMPLANT
K911516 · Implantech Associates, Inc. · Jul 1991
FLOWERS CHIN IMPLANT
K905267 · Implantech Associates, Inc. · Jan 1991
FLOWERS JOWL IMPLANT
K905268 · Implantech Associates, Inc. · Jan 1991
EXTENDED CHIN IMPLANT STYLE I
K902824 · Implantech Associates, Inc. · Aug 1990
EXTENDED CHIN IMPLANT STYLE II
K902825 · Implantech Associates, Inc. · Aug 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826 · Implantech Associates, Inc. · Aug 1990