What To Know
- The Additive 3D-printed Patient Specific Talus Spacer was approved on February 17, 2021 by the US Food and Drug Administration (“FDA”) and is the first and only patient-specific total talus replacement implant authorized for use in the United States.
- It is designed to replace the talus, the bone in the ankle that connects the leg and foot.
Paragon 28, Inc., a market-leading orthopedic medical device company focused exclusively on the foot-and-ankle, today announced that the Company has acquired the product lines of Additive Orthopaedics (“Additive”).
The Additive 3D-printed Patient Specific Talus Spacer was approved on February 17, 2021 by the US Food and Drug Administration (“FDA”) and is the first and only patient-specific total talus replacement implant authorized for use in the United States. The FDA approved the implant as a humanitarian use device. It is designed to replace the talus, the bone in the ankle that connects the leg and foot. The Additive implant provides patients access to a novel, joint-sparing alternative to traditional ankle fusion therapies.
Also acquired as part of the transaction was Additive’s internally developed, proprietary pre-operative surgical planning application to assist in surgical planning. The application is an end-to-end, fully integrated cloud-based communication tool that aligns surgeons and engineers to design patient specific surgical plans and implants, optimizing patient outcomes.
“The addition of the Additive Orthopaedics product portfolio and surgical planning capabilities provides Paragon 28 customers exclusive access to the only FDA-approved patient specific total talus replacement implant,” said Albert DaCosta, Co-Founder and Chief Executive Officer of Paragon 28. “The Additive acquisition also significantly accelerates the Company’s strategy to leverage smart tools, artificial intelligence and advanced technology to improve patient outcomes.”
