Paragon 28's Paratrooper Plantar Plate Repair System receives FDA 510(k) clearance

Monday February 10, 2020 0 comments Tags: Englewood, Paragon 28, Paratrooper Plantar Plate System

ENGLEWOOD -- Paragon 28 announced its Paratrooper Plantar Plate Repair System, developed to allow surgeons to use a dorsal or plantar approach to the plantar plate repair procedure using a single, all-inclusive kit, has received FDA's 510(k) clearance.paragon-28-logo 

The Paratrooper Plantar Plate Repair System uses an all-suture anchor implant that can be fixed into bone or soft tissue. By using an all-suture implant, the surgeon can perform the plantar plate repair using a variety of fixation and approach techniques, while preserving surrounding bone and tissue, Paragon 28 said. 

When the Paratrooper suture implant is inserted and tensioned, the implanted suture "sock" will contract and form into a low profile, flat anchor that will prevent the implant from pulling out of the site.

Surgeons face a variety of challenges and complications in plantar plate repair using the dorsal and plantar approach:

  • Exposure to the plantar plate from the dorsal approach
  • Difficulty implanting into bone or soft tissue
  • Step-heavy procedure with complicated instrumentation

Paragon 28 said the Paratrooper Plantar Plate Repair System was designed with these challenges in mind.

The system includes all instrumentation necessary to gain adequate exposure to the plantar plate from either the dorsal or plantar approach. 

Paragon 28 designed the Paratrooper Plantar Plate implant and instruments to allow for simple insertion into tissue and bone through use of an innovative insertion tip, custom needle, and delivery method.

Instrumentation is provided to directly address plantar plate deficiency and is included within one kit and is used to facilitate exposure, drilling, and implant placement within a small, limited vascularization environment. 

The Paratrooper Plantar Plate Repair System was specifically designed to facilitate proper step execution and limit complications intraoperatively.

Paragon 28 said it is planning for full commercial launch of the Paratrooper Plantar Plating System in June of this year.