Cleared Traditional

K910655 - COMBINED MALAR IMPLANT

K910655 is an FDA 510(k) clearance for COMBINED MALAR 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 42-day FDA review.

K910655 · Implantech Associates, Inc. · General & Plastic Surgery device
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Mar 1991
Decision
42d
Days
Class 2
Risk

K910655 is an FDA 510(k) clearance for the COMBINED MALAR 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 March 28, 1991 after a review of 42 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 Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K910655

510(k) Number K910655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date March 28, 1991
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 K910655.
ZARA ZONE IV MALAR IMPLANT
K914016 · Byron Medical · Dec 1991
TRAPEZOIDAL MALAR IMPLANT
K911513 · Implantech Associates, Inc. · Jul 1991
EXTENDED MALAR IMPLANT
K911515 · Implantech Associates, Inc. · Jul 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