Cleared Traditional

K914016 - ZARA ZONE IV MALAR IMPLANT

K914016 is an FDA 510(k) clearance for ZARA ZONE IV MALAR IMPLANT, manufactured by Byron Medical. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K914016 · Byron Medical · General & Plastic Surgery device
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Dec 1991
Decision
87d
Days
Class 2
Risk

K914016 is an FDA 510(k) clearance for the ZARA ZONE IV MALAR IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on December 5, 1991 after a review of 87 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 Byron Medical devices

FDA 510(k) Submission Details - K914016

510(k) Number K914016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date December 05, 1991
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 15
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K914016.
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · Implantech Associates, Inc. · Jan 1995
ZARA ZONE IV MALAR IMPLANT MODIFICATION
K934233 · Byron Medical · Feb 1994
FLOWERS MEDIAL MALAR IMPLANT
K921582 · Implantech Associates, Inc. · May 1992
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