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July 23, 2015 | By Simon

While we’ve seen just how much of an impact additive manufacturing has had on the medical industry - such as creating 1:1 model replicas of anatomical features for medical professionals in advance of a surgical procedure - a new generation of 3D printing materials and technologies are increasingly being approved for implanting into the human body.

Today, Oxford Performance Materials, Inc (OPM), a leading advanced materials and 3D printing company with a focus on personalized medicine, has announced that they have received 510(k) clearance from the FDA for its first-in-kind SpineFab® VBR implant system.

OPM is also the first company to receive FDA clearance to manufacture 3D printed patient-specific polymeric implants for its cranial prostheses line, which it received in February 2013, followed by facial implants in July 2014.    

The company’s new SpineFab system is the first and only FDA cleared 3D printed load-bearing polymer device designed for long-term implantation, along with their other 3D printed implant designs.   

"Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM," said Scott DeFelice, Chief Executive Officer and Chairman of Oxford Performance Materials.

"This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts and mission critical robust structures. The introduction of our SpineFab system represents exciting news for the Company's entry into the attractive spinal market, and this lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry."

Designed to be used as a vertebral body replacement (VBR) in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, the SpineFab is manufactured by OPM Biomedical, an original equipment manufacturer (OEM) of medical devices, using a laser sintering process that utilizes human-safe OXPEKK® powder formulation biopolymers.  The resulting 3D prints features a unique and beneficial set of attributes, including radiolucency, bone-like mechanical properties, and bone osseoincorporation characteristics.  

"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," said Severine Zygmont, President of OPM Biomedical.

"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."

The company is currently talking with a number of distributors to determine the best partnership options for selling the orthopedic devices, however the company’s existing OsteoFab Patient-Specific Cranial and Facial devices are distributed exclusively by Zimmer Biomet.

 

 

Posted in 3D Printing Applications

 

 

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