Oxford Performance Materials out of South Windsor, Connecticut received the first FDA clearance for a 3D printed polymeric implant for facial reconstruction. The OsteoFab Patient-Specific Facial Device (OPSFD) is uniquely manufactured for individual patient anatomies using MRI or CT scans as templates.
The implants can be produced with a level of detail previously unavailable, allowing for improved outcomes following challenging surgeries. They are produced out of the company’s OXPEKK powder material and 3D printed using laser sintering additive technology.
The implants are biocompatible, radiolucent, and similar to bone in a number of ways, including being able to support bone attachments.
From the announcement:
OPM technology is also designed to reduce the overall “cost of ownership” to the customer by decreasing operating room time, hospital length of stay and procedure complications. In addition, OsteoFab customers do not pay a premium for the individualized 3D printed implant.
“An exciting aspect of our technology is that additional complexity does not increase manufacturing cost, and having both cranial and facial devices cleared now enables us to answer ever more complex cases where upper facial structures can be incorporated with cranial implants as a single device,” added Severine Zygmont, President of OPM Biomedical. “As a result, additive manufacturing has the potential to not only improve patient outcomes, but fundamentally improve the economics of orthopedics on a global scale – for developed and developing countries. These are disruptive changes that will allow the industry to provide the finest levels of healthcare to more people at a lower cost.”