FDA Clears OPM's Spinal Implants

Oxford Performance Materials was oxpekk oxford performance materials

 Oxford Performance Materials’ biocompatible OXPEKK material.

Severine Zygmont, President of OPM Biomedical, adds, “We have built a strategy with the patient in mind by working together with clinicians to bring innovative device solutions that anticipate improved surgical outcomes. Today we have achieved our goal to build the first 3D printed polymer implant that has been cleared for a load bearing indication. Our OsteoFab process, which combines 3D printing with a unique material chemistry, is causing the industry to rethink how implants are designed and manufactured. We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable.”

Their biomedical division, OPM Biomedical, plans to 3D print the implants in 48 sizes using their certified OsteoFab laser sintering process and biocompatible OPEKK powder.  This surprises me, in that one of the great benefits of 3D printing is the ability to translate patient medical data into perfectly-tailored medical devices.  So, to hear that they will be 3D printing 48 different sizes seems to resemble the strategy of a traditional manufacturer.  The company does suggest that their implants allow X-Rays to pass through them, feature bone-like mechanical properties, and facilitate bone growth.  As Zygmont indicates above, doctors will be able to read the implants via X-Ray just as they might a biological bone, allowing them to track bone growth, which may be beneficial enough to warrant the unique 3D printing powder and process.

OPM plans to sell these implants through distributors, along with future orthopedic implants that the company is developing.  Their previous implants, the OsteoFab Patient-Specific Cranial and Facial devices, however, are exclusively distributed through Zimmer Biomet.