Cleared Traditional

K992242 - PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS

K992242 is an FDA 510(k) clearance for PILLAR NASAL, manufactured by Pillar Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K992242 · Pillar Surgical, Inc. · General & Plastic Surgery device
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Nov 1999
Decision
143d
Days
Class 2
Risk

K992242 is an FDA 510(k) clearance for the PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Pillar Surgical, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 22, 1999 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pillar Surgical, Inc. devices

FDA 510(k) Submission Details - K992242

510(k) Number K992242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date November 22, 1999
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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 26
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K992242.
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB · Jun 2009
MONARCH NASAL IMPLANT
K071018 · Hanson Medical, Inc. · May 2007
MONARCH NASAL IMPLANT
K041690 · Hanson Medical, Inc. · Feb 2005
NASAL DORSAL SERIES
K983755 · Surgical Technology Laboratories, Inc. · Nov 1998
SEARE BIOMEDICAL NASAL IMPLANTS
K982753 · Seare Biomedical Corp. · Sep 1998
SILIMED NASAL L SHAPED IMPLANT
K981833 · Silimed, LLC · Jun 1998