Cleared Traditional

K942420 - IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT

K942420 is an FDA 510(k) clearance for IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT, manufactured by King & Spalding. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K942420 · King & Spalding · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
80d
Days
Class 2
Risk

K942420 is an FDA 510(k) clearance for the IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by King & Spalding (Washington, US). The FDA issued a Cleared decision on August 8, 1994 after a review of 80 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 King & Spalding devices

FDA 510(k) Submission Details - K942420

510(k) Number K942420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date August 08, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
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 K942420.
MENISCUS CHIN IMPLANT
K944164 · Spectrum Designs, Inc. · Nov 1994
SILHOUETTE MALAR IMPLANT
K944165 · Spectrum Designs, Inc. · Nov 1994
DORSAL COLUMELLA IMPLANT
K944166 · Spectrum Designs, Inc. · Nov 1994
ZARA ZONE IV MALAR IMPLANT MODIFICATION
K934233 · Byron Medical · Feb 1994
FLOWERS MEDIAL MALAR IMPLANT
K921582 · Implantech Associates, Inc. · May 1992
ZARA ZONE IV MALAR IMPLANT
K914016 · Byron Medical · Dec 1991