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Native Orthopedics wins manufacturing voucher to test knee suture device
Summary
The board approved a manufacturing voucher for Native Orthopedics to mechanically test a single‑motion tensioning suture implant aimed at reducing full knee replacements; presenters said an FDA 510(k) submission is imminent and the company holds multiple patents.
The board approved a manufacturing innovation voucher for Native Orthopedics, a Providence‑based medical device company, to support mechanical testing and validation of a suture‑tensioning implant intended to treat meniscal and early-stage knee problems.
Tom Gamache, identified in the meeting as Native Orthopedics’ CEO and cofounder, said the device allows a surgeon to suture, tension and retension a meniscal repair without changing standard procedural flow and that the company is preparing an FDA 510(k) submission. Gamache told the board the company has “11 issued patents as of today” and broader global protection. Board members discussed clinical use cases, testing and how the product might expand to other joints; the board approved the voucher by voice vote.
