FDA Approves Onkos Surgical’s 3D Printed Collar Implants

Formnext Germany

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Specialized MedTech company Onkos Surgical has received FDA 510(k) clearance to market its modular collars used for musculoskeletal oncology and complex orthopedic limb salvage surgery. Made specific to each patient with 3D printing technology, these devices improve bone infusion and, according to the company, reduce the clinical challenges associated with implant loosening for orthopedic limbs.

Limb salvage surgery is a procedure that extracts tumors from limbs without having to remove the entire limb. Even if a small amount of the cancer is left, it can spread to other regions of the body. So, often the surrounding bone and tissue will also be taken and, in such cases, an implant may be used to restore the look and function of the limb.

Image courtesy of Onkos Surgical.

Aseptic loosening failures are a leading cause of limb salvage prosthesis failure and initial implant fixation is critical for long-term patient success. Onkos’s BioGrip collars are 3D-printed and include Nano HA treatment to help provide bone ingrowth at the bone-implant interface. The nano hydroxyapatite coating decreases degradation rates and promotes porous calcium induced osteogenesis. The patented design is now available as part of the ELEOS Limb Salvage System. About 3,610 new cases of bone cancer will be diagnosed in 2021 and this portfolio of collars is designed to help further ensure the best possible patient outcomes.

Onkos Surgical was founded in 2015 with the goal of improving the clinical challenges that come with tumor surgery. In 2018 they partnered with 3D Systems, gaining access to 3D Systems’ Virtual Surgical Planning (VSP) product line, as well as working together to receive FDA clearance. In 2019 the two firms received FDA 510(k) clearance for VSP, providing surgeons a clear, 3D anatomical representation of their patients before going into surgery. Through a cloud-based software, surgeons have the ability to share images with a concierge engineering team to create a 3D virtual planning environment.

It’s no surprise the positive effects 3D printing has had in healthcare. For example, surgeons are now able to customize tools to their liking instead of using mass-produced instruments which might not suit their grip, hand size, or specific techniques. As seen with Onkos Surgical, prosthetics and medical devices can be made to each patient’s unique biological specifications, even allowing doctors to plan operations and test different scenarios.

3D printing allows fabrication of prosthetics that are not able to be produced in any other way, such as bone implants which are dense yet porous, as seen in the figure below, or feature movable interlocking parts printed as a single unit, whereas other manufacturing techniques would require producing each piece separately and then assembling them together.

Onkos Surgical’s BioGrip 3D printed collars. Image courtesy of Onkos Surgical.

The industry for 3D printed implants has been on the rise for some time now and with great success. This includes treating patients with spinal problems needing implants. Before, patients had to receive already manufactured implants, but with 3D printing patients can now receive implants customized to their individual anatomies, which has not only reduced discomfort and revision surgeries but has also prevented paralysis and death. Another such case is research for lower jaw implants, which in the past have had issues with patient rejection, something 3D printing can help by providing patient-specific solutions.

The FDA has run into challenges trying to regulate, oversee, and ensure safety of the medical equipment produced from 3D printing, however. 3D printing now allows for a decentralized and highly customizable form of manufacturing, often by institutions that could have limited experience with FDA guidelines. Since these medical products may be created at the point of care, and the FDA does not have jurisdiction over the practice of medicine, the distinction between product and practice are difficult to discern and regulate.

Nevertheless, at the 2019 Additive Manufacturing Strategies Summit, SmartTech VP of Research, Scott Dunham, estimated the 3D printing healthcare industry to be worth $6.08 billion by 2027 while being valued at $1.25 billion in 2019. An estimated 600,000 implants had been produced in 2019 with that number projected to increase to 4,000,000 in 2027.

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