Cleared Traditional

K133046 - OMNIPORE CUSTOMIZED SURGICAL IMPLANTS

K133046 is an FDA 510(k) clearance for OMNIPORE CUSTOMIZED SURGICAL IMPLANTS, manufactured by Matrix Surgical Holdings, LLC/Matrix Surgical USA. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K133046 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · General & Plastic Surgery device
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May 2014
Decision
229d
Days
Class 2
Risk

K133046 is an FDA 510(k) clearance for the OMNIPORE CUSTOMIZED SURGICAL IMPLANTS. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Matrix Surgical Holdings, LLC/Matrix Surgical USA (Alpharetta, US). The FDA issued a Cleared decision on May 14, 2014 after a review of 229 days - an extended review cycle.

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 Matrix Surgical Holdings, LLC/Matrix Surgical USA devices

FDA 510(k) Submission Details - K133046

510(k) Number K133046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date May 14, 2014
Days to Decision 229 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
114d slower than avg
Panel avg: 115d · This submission: 229d
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 15
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K133046.
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR
K141880 · Ceremed , Inc. · Apr 2015
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
K133809 · Oxford Performance Materials · Jul 2014
SU-POR SURGICAL IMPLANT
K140437 · Poriferous, LLC · Jun 2014
OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
K123908 · Matrix Surgical USA · Jul 2013
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323 · Synthes, Inc. · Nov 2011
STRYKER PATIENT SPECIFIC POLYMER IMPLANT
K103010 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Oct 2010