Cleared Traditional

K140437 - SU-POR SURGICAL IMPLANT

K140437 is an FDA 510(k) clearance for SU-POR SURGICAL IMPLANT, manufactured by Poriferous, LLC. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K140437 · Poriferous, LLC · General & Plastic Surgery device
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Jun 2014
Decision
112d
Days
Class 2
Risk

K140437 is an FDA 510(k) clearance for the SU-POR SURGICAL IMPLANT. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Poriferous, LLC (Newnan, US). The FDA issued a Cleared decision on June 13, 2014 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3500 - 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 Poriferous, LLC devices

FDA 510(k) Submission Details - K140437

510(k) Number K140437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date June 13, 2014
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKY Device Classification - Class 2, Special Controls

Product Code KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3500
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 - KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

All 9
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K140437.
Longeviti PorousFit implant
K211514 · Longeviti Neuro Solutions, LLC · Jul 2021
Biopor, AOC Porous Polyethylene, Cerepor
K160988 · Ceremed , Inc. · Jul 2016
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
K141880 · Ceremed , Inc. · Apr 2015
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2010
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
K080507 · Ceremed , Inc. · Apr 2008
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR
K043133 · Ceremed , Inc. · Mar 2005