Cleared Traditional

K903329 - CUI ANATOMICAL SILICONE MALAR

K903329 is an FDA 510(k) clearance for CUI ANATOMICAL SILICONE MALAR, manufactured by Cui Corp.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K903329 · Cui Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
47d
Days
Class 2
Risk

K903329 is an FDA 510(k) clearance for the CUI ANATOMICAL SILICONE MALAR. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Cui Corp. (Santa Barbara, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 47 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 Cui Corp. devices

FDA 510(k) Submission Details - K903329

510(k) Number K903329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date September 10, 1990
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 K903329.
TRAPEZOIDAL MALAR IMPLANT
K911513 · Implantech Associates, Inc. · Jul 1991
EXTENDED MALAR IMPLANT
K911515 · Implantech Associates, Inc. · Jul 1991
COMBINED MALAR IMPLANT
K910655 · Implantech Associates, Inc. · Mar 1991
ANATOMICAL MALAR IMPLANT
K901662 · Implantech Associates, Inc. · May 1990
BINDER SUBMALAR FACIAL IMPLANT
K894493 · Implantech Associates, Inc. · Oct 1989
BINDER SUBMALAR FACIAL IMPLANT II
K895152 · Implantech Associates, Inc. · Oct 1989