FDA OKs Onkos Surgical’s 3D Printed, Patient-Specific Pelvic Reconstruction

Onkos Surgical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its My3D personalized pelvic reconstruction system.
 
According to the company, the system is the first of its kind with 3D-printed implants, instruments, and models as well as an advanced planning tool for deformity, trauma, disease, and revisions where other treatment or revision failed.
 
The solution includes patient-specific implants for acetabular reconstruction and advanced reconstruction spanning multiple pelvic regions. The implants have unique features to help address challenges of bone and soft tissue attachment and anatomic restoration accuracy.
 
“This offering from Onkos Surgical will greatly advance how I, and my colleagues treat these patients,” Matthew Seidel, MD, orthopedic surgeon with HonorHealth Orthopedics told the press. “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.”
 
My3D includes access to the Onkos uDesign digital ecosystem, where patient images can be sent through a secure, HIPAA-compliant, and cloud-based portal. These images are then rendered into 3D models for a virtual surgical planning session to resect diseased bone and for the precise patient-specific implant.
 
Thanks to this clearance and capability, surgery requirements can be met in six weeks from start to finish.
 
Onkos Surgical co-founder and CEO Patrick Treacy stated, “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.”