Oxford Performance Materials OsteoFab PEKK Study Results

Oxford Performance Materials (OPM) announced results of “A Comparative Study of Three Biomaterials in an Ovine Defect Model: A TETRAfuse® PEKK Study,” examining the in vivo material characteristics of polyetheretherketone (PEEK), titanium-coated PEEK and 3D-printed polyetherketoneketone (PEKK) in a sheep model. Versus PEEK, the PEKK implants displayed bone ingrowth, no fibrotic tissue formation, a significant increase in bony apposition over time and a significantly higher push-out strength.

Scott DeFelice, CEO, said, “OPM’s OsteoFab® technology platform is increasingly recognized as a ‘best of’ solution for CMF and spinal implants, and we will be launching our unique 3D-printed suture anchor product in the coming weeks.”

3D-printed PEKK offers high mechanical integrity, radiographic visibility and osseointegration, as well as antibacterial characteristics.

In the study, PEKK demonstrated a significantly higher push-out force vs. PEEK at eight and 16 weeks post-implantation and also had notably greater bone attachment following pushout when compared to PEEK and Ti-coated PEEK. 3D-printed PEKK also showed substantial bone growth. Within a 2mm radius of the implant, 3D printed PEKK exhibited the highest bone ongrowth percentage when compared to PEEK and Ti-coated PEEK at both the eight 16 weeks.

By directly comparing the three implant materials in an in vivo model, the study showed clear evidence of the performance characteristics at the bone/implant interface. In this instance, 3D-printed PEKK presented a high propensity for bone-ingrowth, no radiographic interference and a material structure that allowed for an increase of integration of cancellous bone into the implant. 3D printed PEKK implants could improve the effectiveness of spinal fusion procedures by promoting osseointegration and decreasing the chance of complications associated with PEEK and Ti-coated PEEK.

OPM has 3D-printed over 70,000 OsteoFab implants under a number of 510(k) clearances and just recently entered the sports medicine arena with a soft tissue fixation device.

 

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