Onkos Surgical received FDA 510(k) clearance to market the My3D® Personalized Pelvic Reconstruction system.
My3D Personalized Pelvic Reconstruction is a first of its kind solution that includes 3D-printed implants, instruments and models, as well as an advanced planning service to treat deformity, trauma, disease and revisions where other treatments or revisions have failed.
Included in the offering are patient-specific implants for both acetabular reconstruction and advanced reconstruction that span multiple regions of the pelvis. The implants are designed and printed with features that help address the challenges of bone and soft tissue attachment and accuracy of anatomic restoration.
The My3D service includes access to the Onkos uDesign® Digital Ecosystem, through which a surgeon can send patient images through a secure, HIPAA compliant cloud-based portal. Anatomical images are then rendered into 3D models for the surgeon to collaborate on a virtual surgical planning session for the resection of the diseased bone and for the implant that matches precisely to the patient. Surgery requirements can be met in six weeks from start to finish.
Onkos Surgical CEO Patrick Treacy said, “This clearance is a major milestone for Onkos Surgical as we continue to leverage our experience and expertise in 3D planning and printing to optimize patient specific solutions for complex orthopaedic conditions. We founded the company with the belief that patients with these challenging conditions deserve solutions designed specifically for them. Our My3D platform and Digital Ecosystem enable us not only to provide that personalized solution faster, but also to lay the foundation for future clearances in musculoskeletal personalization.”
Onkos Surgical received FDA 510(k) clearance to market the My3D® Personalized Pelvic Reconstruction system.
My3D Personalized Pelvic Reconstruction is a first of its kind solution that includes 3D-printed implants, instruments and models, as well as an advanced planning service to treat deformity, trauma, disease and revisions where other...
Onkos Surgical received FDA 510(k) clearance to market the My3D® Personalized Pelvic Reconstruction system.
My3D Personalized Pelvic Reconstruction is a first of its kind solution that includes 3D-printed implants, instruments and models, as well as an advanced planning service to treat deformity, trauma, disease and revisions where other treatments or revisions have failed.
Included in the offering are patient-specific implants for both acetabular reconstruction and advanced reconstruction that span multiple regions of the pelvis. The implants are designed and printed with features that help address the challenges of bone and soft tissue attachment and accuracy of anatomic restoration.
The My3D service includes access to the Onkos uDesign® Digital Ecosystem, through which a surgeon can send patient images through a secure, HIPAA compliant cloud-based portal. Anatomical images are then rendered into 3D models for the surgeon to collaborate on a virtual surgical planning session for the resection of the diseased bone and for the implant that matches precisely to the patient. Surgery requirements can be met in six weeks from start to finish.
Onkos Surgical CEO Patrick Treacy said, “This clearance is a major milestone for Onkos Surgical as we continue to leverage our experience and expertise in 3D planning and printing to optimize patient specific solutions for complex orthopaedic conditions. We founded the company with the belief that patients with these challenging conditions deserve solutions designed specifically for them. Our My3D platform and Digital Ecosystem enable us not only to provide that personalized solution faster, but also to lay the foundation for future clearances in musculoskeletal personalization.”
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