Cleared Traditional

K971479 - DURALASTIC ANATOMICAL MALAR IMPLANTS

K971479 is an FDA 510(k) clearance for DURALASTIC ANATOMICAL MALAR IMPLANTS, manufactured by Allied Biomedical Corp.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K971479 · Allied Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
86d
Days
Class 2
Risk

K971479 is an FDA 510(k) clearance for the DURALASTIC ANATOMICAL MALAR IMPLANTS. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Allied Biomedical Corp. (Paso Robles, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 86 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 Allied Biomedical Corp. devices

FDA 510(k) Submission Details - K971479

510(k) Number K971479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1997
Decision Date July 18, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 30
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K971479.
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
K980141 · Spectrum Designs, Inc. · Mar 1998
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · Implantech Associates, Inc. · Nov 1997
DURALASTIC ANATOMICAL MALAR IMPLANT
K973574 · Hanson Medical, Inc. · Oct 1997
BONE SOURCE HYDROXYAPATITE
K970400 · Orthofix, Inc. · May 1997
SURGIFORM ANATOMICAL MALAR
K964443 · Surgical Technology Laboratories, Inc. · Dec 1996
IMPLANTECH WM NASAL-LABIAL IMPLANT
K962261 · Implantech Associates, Inc. · Aug 1996