Cleared Traditional

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) (K091011) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091011 · Surgical Technology Laboratories, Inc ("Stl") · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
13d
Days
Class 2
Risk

K091011 is an FDA 510(k) clearance for the PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER). Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Surgical Technology Laboratories, Inc ("Stl") (Columbia, US). The FDA issued a Cleared decision on April 22, 2009 after a review of 13 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 Surgical Technology Laboratories, Inc ("Stl") devices

Submission Details

510(k) Number K091011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date April 22, 2009
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
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