Paragon 28’s Patient Specific Titanium Talus Spacer Approved by FDA

By Julie A. Vetalice

Paragon 28’s Patient Specific Titanium Talus Spacer Approved by FDA

Paragon 28 received a supplemental approval order from FDA for the Patient Specific Talus Spacer. The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating.

The Patient Specific Talus Spacer was first approved by FDA under a Humanitarian Device Exemption in early 2021 for treatment of avascular necrosis of the ankle joint. Shortly after, Paragon 28 acquired Additive Orthopaedics, the system's manufacturer.

Originally approved in cobalt chromium metal alloy, the talus spacer is now available in titanium with a titanium nitride coating. The surgeon selects which material is best suited for the patient.

The Patient Specific Talus Spacer remains the first and only patient specific total talus replacement implant authorized for use in the United States. The implant is designed to replace the talus, an ankle bone that connects the leg and foot, providing patients access to a novel, joint-sparing alternative to amputation or traditional ankle fusion therapies.

Albert DaCosta, President and CEO of Paragon 28, commented, “P28 now has expanded material options available for the first and only FDA approved patient specific total talus replacement implant. P28 will continue to invest in patient specific solutions to help surgeons address unique and complex clinical challenges. We thank the FDA for a tremendous partnership during this process.”

Source: Paragon 28, Inc.

Product Labels: Ankle Replacement

Tags: 510(k) Clearance, Regulatory