Cleared Traditional

K894493 - BINDER SUBMALAR FACIAL IMPLANT

K894493 is an FDA 510(k) clearance for BINDER SUBMALAR FACIAL IMPLANT, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K894493 · Implantech Associates, Inc. · General & Plastic Surgery device
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Oct 1989
Decision
100d
Days
Class 2
Risk

K894493 is an FDA 510(k) clearance for the BINDER SUBMALAR FACIAL IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K894493

510(k) Number K894493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1989
Decision Date October 27, 1989
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 32
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K894493.
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 II
K895152 · Implantech Associates, Inc. · Oct 1989
BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR
K863400 · Byron Medical · Sep 1986