Cleared Traditional

K902824 - EXTENDED CHIN IMPLANT STYLE I

K902824 is an FDA 510(k) clearance for EXTENDED CHIN IMPLANT STYLE I, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K902824 · Implantech Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
34d
Days
Class 2
Risk

K902824 is an FDA 510(k) clearance for the EXTENDED CHIN IMPLANT STYLE I. 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 1, 1990 after a review of 34 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

FDA 510(k) Submission Details - K902824

510(k) Number K902824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date August 01, 1990
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 46
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K902824.
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 II
K902825 · Implantech Associates, Inc. · Aug 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826 · Implantech Associates, Inc. · Aug 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE II
K902827 · Implantech Associates, Inc. · Aug 1990