My3D Personalized Pelvic Reconstruction receives 501(k) clearance

Onkos Surgical, a leading innovator of solutions for musculoskeletal oncology and complex orthopedic procedures, has received 510(k) clearance for its My3D Personalized Pelvic Reconstruction system – the 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 My3D Personalized Pelvic Reconstruction 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 unique features that help address the challenges of bone and soft tissue attachment, and accuracy of anatomic restoration.

“This offering from Onkos Surgical will greatly advance how I, and my colleagues treat these patients,” said Matthew Seidel, MD, orthopedic surgeon with HonorHealth Orthopedics in Scottsdale, Arizona. “Patients with these conditions of the pelvis have many clinical challenges. Historically, our implant options are mass-produced and may not be best suited for the individuality that each patient requires. With this platform, Onkos has developed a process that allows me to virtually plan the surgery in advance and delivers a patient-specific implant and instruments in a matter of weeks. It changes the way I can treat my patients.”

The My3D service includes access to the Onkos uDesign Digital Ecosystem – where 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. With this clearance and capability, Onkos can meet surgery requirements in 6 weeks from start to finish.

“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 orthopedic 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,” stated Patrick Treacy, Onkos Surgical Co-Founder, and CEO.

More than 350 leading medical institutions in the US choose Onkos’ innovative Precision Orthopaedics solutions. This approach supports improved patient outcomes and experiences, leveraging the latest innovations in virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization.