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3D Printed Pelvic Implants from Onkos Surgical Earn FDA Clearance https://ift.tt/v5VTrdJ The medical field is, rightly so, a highly regulated one, and you can’t really get momentum for a product until it’s received clearance from the U.S. Food and Drug Administration (FDA). Last summer, specialized medtech company Onkos Surgical was cleared by the FDA to market its 3D printed collar implants for musculoskeletal oncology and complex orthopedic limb salvage surgery, and now the company has announced that it has earned the coveted FDA 510(k) clearance for its My3D personalized pelvic reconstruction system, which includes 3D printed implants, models, instruments, and an advanced surgical planning tool.
Onkos says that because of the FDA clearance, the pelvic reconstruction platform can meet surgical requirements in just six weeks. The company also claims that the My3D system is “the first of its kind” to include not only 3D printed patient-specific implants, models, and instruments, but also access to an advanced tool to use for planning purposes in the face of disease, deformity, trauma, and revisions that couldn’t be fixed by other treatments. The platform is used by surgeons to develop these personalized medical devices for surgeries.
The My3D solution includes 3D printed patient-specific implants, with “unique” features, for acetabular reconstruction, as well as advanced reconstruction of several pelvic regions. The company says these features help with anatomic restoration accuracy, as well as encouraging soft tissue and bone attachment and growth, the latter of which is known as ossification. My3D also offers access to the Onkos uDesign digital ecosystem, which “enables a personalized planning approach for each patient,” according to the website. Patient images, like CT scans, can be sent through a cloud-based, secure, HIPAA-compliant portal, and segmented by high-quality image processors in order to create 3D models of both hard and soft tissue. Then the surgeon, together with ONKOS technical experts, reviews the models in a virtual planning session to come up with the best pre- and intra-operative surgical solutions and ensure better patient outcomes. In February of 2023, 3DPrint.com and SmarTech Analysis will once again be holding our Additive Manufacturing Strategies summit in New York City. This event will include keynote presentations and panels focused on nine vertical topics that are critical in the continually-growing world of additive manufacturing, including 3D printing for healthcare. Register now to join us in these important discussions! (Image via Onkos Surgical) The post 3D Printed Pelvic Implants from Onkos Surgical Earn FDA Clearance appeared first on 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing. Printing via 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing https://ift.tt/qDcJezA July 22, 2022 at 07:12AM
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