Cleared Traditional

K992239 - PILLAR CHIN IMPLANT

K992239 is an FDA 510(k) clearance for PILLAR CHIN IMPLANT, manufactured by Pillar Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K992239 · Pillar Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
143d
Days
Class 2
Risk

K992239 is an FDA 510(k) clearance for the PILLAR CHIN IMPLANT. Classified as Prosthesis, Chin, Internal (product code FWP), 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 878.3550 - 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: 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 - K992239

510(k) Number K992239 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.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
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 - FWP Prosthesis, Chin, Internal

All 48
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K992239.
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K121315 · Howmedica Osteonics Corp. · Nov 2012
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
K091011 · Surgical Technology Laboratories, Inc ("Stl") · Apr 2009
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K012350 · Porex Surgical, Inc. · Mar 2002
STANDARD CHIN
K983754 · Surgical Technology Laboratories, Inc. · Nov 1998
SEARE BIOMEDICAL CHIN IMPLANTS
K982752 · Seare Biomedical Corp. · Sep 1998
SILIMED CHIN IMPLANTS
K981850 · Silimed, LLC · Jul 1998