Cleared Traditional

K021419 - AART MALAR IMPLANT

K021419 is an FDA 510(k) clearance for AART MALAR IMPLANT, manufactured by Aesthetic and Reconstructive Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K021419 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
60d
Days
Class 2
Risk

K021419 is an FDA 510(k) clearance for the AART MALAR IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Aesthetic and Reconstructive Technologies, Inc. (Reno, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 60 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 Aesthetic and Reconstructive Technologies, Inc. devices

FDA 510(k) Submission Details - K021419

510(k) Number K021419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date July 02, 2002
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZK Device Classification - Class 2, Special Controls

Product Code LZK Implant, Malar
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 - LZK Implant, Malar

All 33
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K021419.
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
K002886 · Implantech Associates, Inc. · Nov 2000
PILLAR MALAR IMPLANT
K992240 · Pillar Surgical, Inc. · Nov 1999
SURGIFORM ANATOMICAL MALAR
K983756 · Surgical Technology Laboratories, Inc. · Nov 1998
SEARE BIOMEDICAL MALAR IMPLANTS
K982763 · Seare Biomedical Corp. · Sep 1998
SILIMED MALAR IMPLANT
K981835 · Silimed, LLC · Jul 1998
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
K980139 · Spectrum Designs, Inc. · Mar 1998