Carbon22 Receives FDA’s 510(k) Clearance for its Apollo Ankle-Fracture Plating System

March 15, 2022

Carbon22 has received 510(k) marketing clearance from the FDA for its Apollo ankle-fracture plating system.

The system includes “ortholucent” bone plates and screws for orthopedic ankle-fracture surgery that allow x-rays to see through the implants for improved visualization of bones and joints.

The implant system, which features a composite of titanium and a PEEK (polyetheretherketone) polymer, is the latest addition to the company’s foot and ankle device offerings, which also includes Creed ortholucent compression screws.

The Englewood Cliffs, N.J.-based company expects to begin marketing the newly cleared system in the U.S. later this spring.

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