Cleared Traditional

K071018 - MONARCH NASAL IMPLANT

K071018 is an FDA 510(k) clearance for MONARCH NASAL IMPLANT, manufactured by Hanson Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K071018 · 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
May 2007
Decision
45d
Days
Class 2
Risk

K071018 is an FDA 510(k) clearance for the MONARCH NASAL IMPLANT. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - 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 - K071018

510(k) Number K071018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2007
Decision Date May 25, 2007
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 - FZE Prosthesis, Nose, Internal

All 32
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K071018.
Osseointegrated Fixtures
K161548 · Southern Implants (Pty), Ltd. · Dec 2016
HANSON MEDICAL FACIAL IMPLANTS
K090803 · Hanson Medical, Inc. · Jun 2010
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB · Jun 2009
MONARCH NASAL IMPLANT
K041690 · Hanson Medical, Inc. · Feb 2005
AART NASAL IMPLANT
K021418 · Aesthetic and Reconstructive Technologies, Inc. · Jul 2002
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
K992242 · Pillar Surgical, Inc. · Nov 1999