Study of 3D-Printed OsteoFab Structures Details PEKK Antibacterial Benefits

Oxford Performance Materials Inc. (OPM), a firm specializing in advanced materials science and high performance additive manufacturing (HPAM), announced the results of an independent scientific study that reveals superior antibacterial properties of 3D printed PEKK (poly-ether-ketone-ketone) structures vs. conventional PEEK (poly-ether-ether-ketone) surfaces for orthopedic applications. The September 2017 study¹ examined 3D printed PEKK samples produced by OPM’s proprietary OsteoFab process and “demonstrated for the first time the promise that nanostructured² PEKK has for numerous anti-infection orthopedic implant applications.”
 
OPM’s OsteoFab technology was first commercialized in 2013 and utilizes the company’s exclusive OXPEKK material, a high performance PEKK polymer formulation that meets FDA and EU requirements for long-term implantable medical device applications. The properties of OPM’s OXPEKK polymer and OsteoFab 3D printing technology combine to form an inherently rough, nanostructured surface that has been demonstrated to enhance bone attachment.³
 
The antibacterial attributes of 3D printed PEKK are significant, since they address two areas of growing concern in medicine. “Orthopedic implant infections have been steadily increasing while, at the same time, antibiotics developed to kill such bacteria have proven less and less effective with every passing day,” according to the researchers. “It is clear that new approaches that do not rely on the use of antibiotics are needed to decrease medical device infections.” As a result, the antibacterial properties detailed in this new study that apply to OsteoFab devices will provide another important layer of differentiation for the performance of OPM medical devices in the marketplace.
 
Dr. Gregory Chotkowski, Board Certified Oral and Maxillofacial surgeon, commented on the comparative benefits of OsteoFab devices: “I am excited that there is another option available for custom facial bony augmentation. The products currently available are porous and have a high incidence of infection when placed through a transoral surgical approach,” Dr. Chotkowski stated, “I had the opportunity to use OPM’s 3D printed PEKK mandibular angle implants on several occasions and feel that this material is far superior. The bacteriostatic properties—combined with custom fabrication—makes this an ideal material for facial augmentation through a transoral approach.”
 
Five FDA 510(k) clearances have been obtained for OsteoFab devices. OPM is the only company with FDA clearances for 3D printed polymeric implants, and the company was granted a patent from the European Patent Office for its “Customized Implant for Bone Replacement” manufacturing process. In addition to obtaining its own clearances, OPM has customers that have obtained regulatory approvals for devices made from OXPEKK polymer in Asia, Europe, and South America. The company is an OEM of its craniomaxillofacial (CMF) OsteoFab implant line, which is exclusively distributed worldwide by Zimmer Biomet. Over 1,700 patient specific cranial and facial devices have been shipped to date, and the OsteoFab facial line was officially launched earlier this year.
 
OPM recently introduced its OsteoFab technology to the spinal device market through its partnership with U.S.-based RTI Surgical. RTI announced last month the commercial launch of Fortilink-C IBF System with TETRAfuse 3D Technology. The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device to incorporate macro, micro and nano-rough features beyond the endplate surfaces to the entire implant surface. Today, OPM is well positioned to produce a full range of standard sizes in spine, providing OPM with the first high volume, mass application for its OsteoFab 3D printing technology using its proprietary OXPEKK polymer.

References
¹“Antibacterial Properties of PEKK for Orthopedic Applications,” International Journal of Nanomedicine, Dovepress 15-Sep-2017, Mian Wang, Garima Bhardwaj (Department of Chemical Engineering, Northeastern University, Boston MA) and Thomas J. Webster (Department of Chemical Engineering, Northeastern University, Boston MA and Wenzhou Institute of Biomaterials and Engineering, Wenzhou Medical University, Wenzhou, China). The full study by Mian Wang, et al. may be viewed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5592909/
²Nanostructured materials are those having properties defined by features smaller than 100 nanometers.
³Hacking, Adam, “The Tissue Response to PEKK Femoral Rods Implanted in the Medullary Canal of the Rabbit Femur”. OPM Internal Report, January 23, 2013.