Cleared Special

K161052 - OsteoFab Patient Specific Facial Device

K161052 is an FDA 510(k) clearance for OsteoFab Patient Specific Facial Device, manufactured by Oxford Performance Materials, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KKY cleared through the Special 510(k) pathway after a 97-day FDA review.

K161052 · Oxford Performance Materials, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
97d
Days
Class 2
Risk

K161052 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, Inc. (South Windsor, US). The FDA issued a Cleared decision on July 20, 2016 after a review of 97 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161052

510(k) Number K161052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2016
Decision Date July 20, 2016
Days to Decision 97 days
Submission Type Special
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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

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 24
Devices cleared under the same product code (KKY) and FDA review panel - the closest regulatory comparables to K161052.
Longeviti PorousFit implant
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Biopor, AOC Porous Polyethylene, Cerepor
K160988 · Ceremed , Inc. · Jul 2016
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 CUSTOMIZED SURGICAL IMPLANTS
K133046 · Matrix Surgical Holdings, LLC/Matrix Surgical USA · May 2014
K161052 · OsteoFab Patient Specific Facial Device
Download PDF FDA Summary Oxford Performance Ma…