ClariVy™ OsteoVy™ PEKK Cervical IBF

 Inherently strong, radiolucent, and with proven osseo-integrative  properties, OXPEKK® represents a novel upgrade to orthopedic plastics.   Further, it can be 3D printed in order to create a truly porous  OsteoVy™ PEKK lattice structure. 

OsteoVy™ PEKK is manufactured from  biocompatible OXPEKK® polymer, which has been evaluated for  osseointegration  through in-vitro and in-vivo studies utilizing animal  models, yielded superior results.  PEKK implants demonstrated bone  ingrowth, no radiographic interference, no fibrotic tissue membrane  formation, significant increase in bony apposition over time, and  significantly

higher push-out  strength compared to standard PEEK. The PEKK implant displayed bone  growth characteristics comparable to Ti-coated PEEK with significant  improvements in implant integrity and radiographic properties.

Cheng,  B., Jaffee, S., Averick, S., Swink, I., Horvath, S., & Zhukauskas,  R. (2020). A comparative study of three biomaterials in an ovine bone  defect model. The Spine Journal, 20(3), 457-464 (data is derived from in  vivo studies)

OsteoVy™  PEKK material demonstrated greater osteoblast adhesion and calcium  deposition on the implant surface compared to PEEK and Titanium.  There  has been shown increased initial calcium and select protein adsorption  on PEKK compared to PEEK and Titanium, the main mechanism of action  which promoted osteoblast density.  Taken together, PEKK demonstrated  optimal surface properties to  promote osteoblast functions.

OsteoFab®  Surface Properties:Bacteria Inhibition and Osteoblast Functions.  Presented by Thomas Webster, Ph.D., Northeastern University October 19,  2020. (data is derived from in vivo studies)

The in vivo bone response to OsteoVy™ PEKK compared to machined PEEK in a rabbit  femoral model at 8 and 12 weeks demonstrated bone growing onto the  surface of a PEKK rod implant and into the peaks and pits of the rough  surface.  However, fibrous tissue (blue) was noted surrounding a PEEK  rod implant.

OPM Internal Study with Yale University – 2014. Data on file at OPM.  (Note: OsteoFab PEKK is another brand name for OsteoVy™ PEKK, data is derived from in vivo studies) 

Results of in vitro study indicated decreased adhesion and growth of P. aeruginosa and S.  epidermidis on nanorough PEKK surface compared with conventional PEEK  surfaces.

Wang,  M., Bhardwaj, G., & Webster, T. (2017). Antibacterial properties of  PEKK for orthopedic applications. International Journal Of  Nanomedicine, Volume 12, 6471-6476 (data is derived from in vivo  studies)

 OsteoVy™ PEKK material has demonstrated extraordinary vertical fluid conduction through its roughened outer surface, and even more so within the OsteoVy™ lattice structure.