Onkos Surgical Announces FDA 510(k) Clearance of its BioGrip® Modular Porous Collars, a First-of-Its-Kind Solution to Help Address Implant Loosening in Orthopaedic Oncology and Complex Revision Surgery
The new offering, available as part of the ELEOS™ Limb Salvage System, is designed to help support bone ingrowth in musculoskeletal oncology and complex orthopaedic limb salvage cases with a novel 3D-printed porous design
PARSIPPANY, N.J., June 22, 2021 /PRNewswire/ -- Onkos Surgical, a leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, today announced that it has received FDA 510(k) clearance for its modular collar portfolio featuring the Company's BioGrip® 3D-printed implant technology. The patented design, now available as part of the ELEOSTM Limb Salvage System, was created to help address the clinical challenge of aseptic loosening (also known as implant loosening) in musculoskeletal oncology and complex orthopaedic limb salvage surgery.
With its new 3D-printed porous structure and novel Nano HA treatment, the BioGrip collar is designed to help provide bone ingrowth at the bone-implant interface which may help address aseptic loosening1. The treatment helps to accelerate and enhance osseointegration2.
The 3D-printed, nano HA treated design is one of two interchangeable collar designs that Onkos has added to its offering to address these complex clinical challenges. The clearance also includes an oval shaped collar design to provide greater contact in distal femoral replacements, where subsidence is a common challenge among complex revision and trauma applications.
"Research has shown that designs treated with hydroxyapatite provide greater surface area for bone ingrowth and may result in lower rates of implant loosening," said Dr. Shervin Oskouei, Division Director of Orthopedic Oncology at Emory University and Chief of Orthopedic Surgery at Emory University Hospital Midtown. "Having this technology available at the bone-implant junction is critical to supporting a reconstruction that may lead to improved implant longevity for these complex procedures."
Patrick Treacy, CEO and co-founder of Onkos Surgical said, "This is a historic day for Onkos Surgical. When we started the company, we set out to deliver innovation that would directly address the long-established clinical challenges of limb salvage surgery - soft-tissue attachment, implant loosening, and infection. In the past six months, we have made significant progress by launching new ELEOS products aimed at improving the challenges of soft tissue attachment. Our latest innovation, the BioGrip collar portfolio, delivers on our promise to help address the challenge of implant loosening. With our focused commercial approach and substantial R&D investments, we will continue to be the leading provider of innovative solutions for musculoskeletal oncology and other complex orthopaedic procedures."
For more information on Onkos Surgical and its solutions, please visit www.onkossurgical.com.
About Onkos Surgical
Onkos Surgical is a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic procedures. With its Precision Orthopaedics approach, surgeons are better informed about patient-specific clinical challenges and can plan and implement a more precise reconstruction. This 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. More than 350 of the leading academic medical institutions in the US choose Onkos Surgical as their partner for Precision Orthopaedics.
Sources
1. Cauthup, et. al. Long-Term Survival of Cemented Distal Femoral Endoprostheses with a Hydroxyapatite-Coated Collar. The Journal of Bone & Joint Surgery: September 4, 2013 - Volume 95 - Issue 17
2. Promimic. Data on File. https://www.promimic.com/wp-content/uploads/2017/09/Introducing-Hydrophilicity-to-Your-Implant-spread.pdf
Forward Looking Statements
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, distribution challenges, market trends and demand, product efficacy and safety concerns, product or raw material availability and other supply constraints. 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:
Andie Levine
Zer0 to 5ive for Onkos Surgical
[email protected]
610-724-5044
Sean Curry
SVP, Commercial Operations - Onkos Surgical
[email protected]
973.264.5400
SOURCE Onkos Surgical
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