Onkos Surgical Receives FDA 510(k) Clearance for 3D Printed, Patient-Specific Pelvic Reconstruction System

Company expands its portfolio of musculoskeletal oncology and complex orthopaedic solutions to include conditions of the pelvis

PARSIPPANY, N.J., July 14, 2022 /PRNewswire/ -- Onkos Surgical, a rapidly growing, leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, today announced that it has received 510(k) clearance for its My3D^® Personalized Pelvic Reconstruction system.

The My3D Personalized Pelvic Reconstruction system is 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 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, AZ. "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. 

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."

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.

For more information on Onkos Surgical and its solutions, please visit www.onkossurgical.com. 

Onkos Surgical is a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic procedures. With our Precision Orthopaedics approach, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement a more precise reconstruction. Our personalized approach supports improved patient outcomes and experiences using the latest innovations in virtual surgical planning, 3D modeling and printing, implant design, and workflow optimization for both adult and pediatric conditions. More than 350 of the leading academic medical institutions in the US choose Onkos Surgical Precision Orthopaedics.

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, market trends and demand. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only as the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law. 

Media Contacts:
Sean Curry
SVP, Commercial Operations
Onkos Surgical 
[email protected]  
973.264.5400

SOURCE Onkos Surgical