Paragon 28

Paragon 28 this week announced that it launched its Monkey Rings circular external fixation system for trauma, deformity correction and limb salvage.

Englewood, Colorado-based Paragon 28 designed the circular external fixation system to use external wires and screws that can be fixed into the bone to maintain anatomic position. The system provides stability, soft tissue preservation and allows for adjustability and functionality.

“P28 is committed to commercializing technologies to enable better outcomes for foot and ankle patients, and the launch of the Monkey Rings circular external fixation is another significant step in the fulfillment of our mission. Combined with the launch of the Monkey Bars pin-to bar external fixation system earlier this year, we are building out a strong external fixation portfolio and complementing our comprehensive internal fixation, biologics and soft tissue options,” CEO Albert DaCosta said in a news release.

Paragon 28 today launched its R3Act stabilization system for acute or chronic syndesmotic ankle injuries.

Englewood, California-based Paragon 28 designed the stabilization system as rigid to allow the syndesmosis to heal during the early stages post-operation. The tibial and fibular components are designed to disengage safely within the clear space once a patient begins to bear weight on the ankle. R3Act also has a pre-tensioned suture loop and thermoplastic polyurethane (TPU) bumpers that allow for diastatic motion and fibular rotation.

“As we continue to learn about syndesmotic injury and repair, it has become evident that there are benefits to both rigid and flexible fixation. The new R3Act stabilization system combines all of the benefits of both options. The early rigidity allows improved primary healing while the suture loop and bumper concept capitalize on the malreduction forgiveness afforded by more flexible fixation,” Lauren Geaney, an R3Act des…

Paragon 28 today announced that it received a supplemental approval order from the FDA for its titanium Patient Specific Talus Spacer.

The supplemental order allows the Englewood, Colorado-based company to additively manufacture the spacer in titanium alloy with a titanium nitride coating. Paragon 28 previously received FDA approval in early 2021 under a humanitarian device exemption to treat avascular necrosis of the ankle joint using the cobalt chromium metal alloy implant.

Paragon 28’s Patient Specific Talus Spacer is a total talus replacement implant that is designed to replace the talus, which connects the leg and foot, to give patients access to joint-sparing alternatives to amputation or ankle fusion therapies.

“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 compl…