Cleared Traditional

K973574 - DURALASTIC ANATOMICAL MALAR IMPLANT

K973574 is an FDA 510(k) clearance for DURALASTIC ANATOMICAL MALAR IMPLANT, manufactured by Hanson Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LZK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K973574 · Hanson Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
35d
Days
Class 2
Risk

K973574 is an FDA 510(k) clearance for the DURALASTIC ANATOMICAL MALAR IMPLANT. Classified as Implant, Malar (product code LZK), Class II - Special Controls.

Submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on October 24, 1997 after a review of 35 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.

FDA 510(k) Submission Details - K973574

510(k) Number K973574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1997
Decision Date October 24, 1997
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 35
Devices cleared under the same product code (LZK) and FDA review panel - the closest regulatory comparables to K973574.
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
K980140 · Spectrum Designs, Inc. · Mar 1998
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 IMPLANTS
K971479 · Allied Biomedical Corp. · Jul 1997
BONE SOURCE HYDROXYAPATITE
K970400 · Orthofix, Inc. · May 1997
SURGIFORM ANATOMICAL MALAR
K964443 · Surgical Technology Laboratories, Inc. · Dec 1996