The Paratrooper system uses an all-suture anchor implant, which can be fixed into bone or soft tissue
Paragon 28 has secured FDA 510(k) clearance for Paratrooper plantar plate system (Credit: PRNewswire / Paragon 28, Inc)
Paragon 28 has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Paratrooper plantar plate repair system.
The Paratrooper system enables surgeons to repair the plantar plate through either a dorsal or plantar approach by using a single and all-inclusive kit.
Paragon 28’s system utilises an all-suture anchor implant, which can be fixed into bone or soft tissue.
The surgeon can carry out the plantar plate repair by using an all-suture implant and a variety of fixation and approach techniques to preserve the surrounding bone and tissue.
The implanted suture sock will contract and form into a low profile, flat anchor to prevent the implant from pulling out of the site when the Paratrooper suture implant is inserted and tensioned.
Surgeons will have multiple challenges and complications in plantar plate repair while applying the dorsal and plantar approach, including exposure to the plantar plate from the dorsal approach, difficulty implanting into bone or soft tissue and step-heavy procedure with complicated instrumentation
The company has designed Paratrooper plantar plate repair system to address these challenges.
Paratrooper system features all instrumentation to deliver adequate exposure to the plantar plate from either the dorsal or plantar approach
Paratrooper system features all instrumentation required to provide adequate exposure to the plantar plate from either the dorsal or plantar approach.
The Paratrooper plantar plate implant and instruments have been designed to facilitate simple insertion into tissue and bone with the support of insertion tip, custom needle, and delivery method.
Instrumentation will help directly address plantar plate deficiency and is present within one kit, as well as helps to facilitate exposure, drilling, and implant placement within a small, limited vascularisation environment.
The company has specifically designed the Paratrooper system to enable proper step execution and limit complications intraoperatively.
In addition, the company aims to commercially launch the Paratrooper system in June this year.
In February 2019, Paragon 28 introduced TenoTac soft tissue fixation system for foot and ankle, designed to provide surgeons with a simplified and reproducible option for tendon transfers of the lesser toes.