Cleared Traditional

K133809 - OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

K133809 is an FDA 510(k) clearance for OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE, manufactured by Oxford Performance Materials. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K133809 · Oxford Performance Materials · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
224d
Days
Class 2
Risk

K133809 is an FDA 510(k) clearance for the OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE. Classified as Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (product code KKY), Class II - Special Controls.

Submitted by Oxford Performance Materials (South Windsor, US). The FDA issued a Cleared decision on July 28, 2014 after a review of 224 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 Oxford Performance Materials devices

FDA 510(k) Submission Details - K133809

510(k) Number K133809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date July 28, 2014
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
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
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