While manufacturing technologies are continuously improving the shape and mechanical performance of orthopedic implants, few solutions have been found for optimizing new bone growth and osseointegration without sacrificing device performance.
A preferred method for long-term implant stabilization is the ongrowth or ingrowth of bone tissue. Fixation is important since it enables load transfer between the device and the skeleton. Stabilization can also lead to minimizing pain, reducing risk of fracture or reducing bone loss.
OPM has evaluated osseointegration of OsteoFab®implants through in-vitro and in-vivo studies utilizing animal models.
OsteoFab® parts are manufactured from our biocompatible OXPEKK® polymer using an EOSINT P800 laser sintering system. OXPEKK® polymer has been shown to be safe for long term human implantation in sites with primary bone/tissue contact through extensive testing in accordance with ISO 10993 standards. The OsteoFab® 3D printing process occurs in an inert, sealed chamber at high temperature without human contact, and the entire manufacturing process takes place in an environmentally monitored clean area suite in order to prevent any potential cross-contamination.
The short and long term cell and tissue response to OXPEKK® polymer has been rigorously tested and documented according to ISO 10993 and USP standards.
OXPEKK® polymer is radiolucent for better diagnosis with x-ray and fluoroscopy. It is also MRI and CT compatible, and does not give artifacts during imaging. Additionally, OXPEKK® polymer can be combined with other materials such as barium sulfate to add some opaqueness in order to avoid the need for adding radiographic markers..
OXPEKK® polymer, although stronger than PEEK, still maintains a modulus of elasticity simliar to the a of human cortical bone. This allows for better load sharing of the implant with the newly developing bone.
In addition to its mechanical integrity and radiographic visibility, OXPEKK® demonstrates inherent antibacterial characteristics as well as osseointegrative properties that were confirmed in a study that examined the in vivo material characteristics of PEEK, titanium-coated PEEK and OXPEKK® in a sheep model.