The OsteoFab® technology platform is revolutionizing implant development by accelerating the speed at which implants are designed, manufactured and marketed.
The OsteoFab® implant manufacturing process is additive, building devices layer by layer, using only laser light and OXPEKK® polymer in a nitrogen rich environment. This results in a process where no other manufacturing materials (such as mold release, fluids or solvents) are required, allowing the implant to be produced in an exceptionally clean environment.
OXPEKK® is the proprietary high performance PEKK polymer formulation from OPM for medical applications. OXPEKK® polymers meet the United States FDA and European Union requirements for use in long-term human implantable medical devices. Biocompatibility test data and analytical extraction studies are included in our FDA Master File.
The OsteoFab® platform combines design, material, manufacturing, quality management and regulatory elements into one streamlined process. The benefits of the OsteoFab® technology platform include:
Efficiency – Digital design, refinement and optimization
Effectiveness – Material and process enable facile fabrication of complex parts
Cleanliness & Purity – OPM’s additive manufacturing process has three components in the machine chamber: OXPEKK® powder, laser light and nitrogen gas
FDA Implant Clearances – cranial, facial, and vertebral body replacement
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.
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.
The following are excerpts from “Cell proliferation and vitality determination of osteoblasts on different materials and surface characteristics; Interpretation of laboratory data”, an article by Timothy Ganey, Ph.D. (Download full PDF)
- PEKK has been shown to provide surface adhesion that supports cell activity; maintaining capacity for cell proliferation without exhausting metabolic demands on the cells.
- PEKK offers an efficiency that might be described as metabolically ergonomic; activity proportional to cell need rather than proliferative exaggeration met with high activity per cell requirements as seen in both the smooth and roughened PEEK materials.
- Compared to titanium, greater activity per cell was achieved with the PEKK material at 10 days with fewer cells.
- Expectations with implantation would be for bone attachment, sustained capacity for cell proliferation, sufficient attachment, minimal fibrosis, adequate mineral deposition, and efficient use of cell metabolism.
- Osseointegration is a result of factors that include surface chemistry and morphology of the implanted device.
- Osseointegration has been reported with a variety of titanium and hydroxyapatite-coated implants but is generally not associated with polymers. For example, when placed in an osseous environment, the tissue response to polymeric materials like PEEK (PolyEtherEtherKetone) is generally fibrous(1).
- In an ongoing, OPM sponsored 12-week bilateral implantation study in the rabbit femur, 3D printed PEKK (PolyEtherKetoneKetone), in contrast, has been shown to promote an osseous response similar to titanium when placed in an osseous environment, even without any surface coating. For more details on this study please contact OPM directly.
(1)Olivares-Navarrete R, Hyzy SL, Slosar PJ, et al. Implant Materials Generate Different Peri-implant Inflammatory Factors. Spine2015; 40:399-404.
A Platform for the Future
Biocompatibility, load bearing ability, durability and closeness of fit are all fundamental requirements for musculoskeletal devices. With the adequate design and the right indication for use, the OsteoFab® technology platform is able meet these requirements while enabling new functionality. For example, 3D printing enables the fabrication of complex internal geometries, resulting in channels that could facilitate delivery of therapeutics by perfusion. This technology promises new methods for infection treatment and the delivery of growth factors.
OsteoFab® Technology could provide groundbreaking solutions for the future of musculoskeletal repair:
- Material and Manufacturing – Low cost and complex geometry
- Novel Functionality – Bone ongrowth and therapeutic delivery
- Treatment Approach – Elevated response and innovative device design
- Streamlined development – Regulatory framework