Cleared Traditional

K133046 - OMNIPORE CUSTOMIZED SURGICAL IMPLANTS

K133046 is the FDA 510(k) clearance for OMNIPORE CUSTOMIZED SURGICAL IMPLANTS by Matrix Surgical Holdings, LLC/Matrix Surgical USA. It is a Class 2 General & Plastic Surgery device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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

Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K133046.
Longeviti PorousFit implant
K211514 · Longeviti Neuro Solutions, LLC · Jul 2021
HTR POLYMER, HTR-MX
K904111 · United States Surgical, A Division of Tyco Healthc · Nov 1990
UHMWPE SURGICAL MESH
K894478 · Biomet, Inc. · Mar 1990
SURG. GOWN & DRAPE, LOW LINT TREATMENT
K781019 · Kimberly-Clark Corp. · Aug 1978