Cleared Traditional

K944164 - MENISCUS CHIN IMPLANT

K944164 is an FDA 510(k) clearance for MENISCUS CHIN IMPLANT, manufactured by Spectrum Designs, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K944164 · Spectrum Designs, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
70d
Days
Class 2
Risk

K944164 is an FDA 510(k) clearance for the MENISCUS CHIN IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 70 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 Spectrum Designs, Inc. devices

FDA 510(k) Submission Details - K944164

510(k) Number K944164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date November 04, 1994
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 22
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K944164.
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · Lifecore Biomedical, Inc. · Jun 1996
SAM FACIAL IMPLANT
K961210 · W.L. Gore & Associates, Inc. · Jun 1996
IMPLANTECH NASAL LABIAL IMPLANT
K943988 · Implantech Associates, Inc. · Jan 1995
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