5 orthopedic devices earning FDA approval

Here are five orthopedic devices and technologies that have received FDA approval, as reported by Becker’s since April 24:

1. Alafair Biosciences earned FDA 510(k) clearance for the VersaCoat tendon protector and VersaCoat nerve protector.
2. Exactech’s Equinoxe scapula reconstruction system earned FDA 510(k) clearance.
3. Stryker secured FDA clearance for its Incompass total ankle system to treat patients whose ankle joints have been damaged by severe rheumatoid, post-traumatic or degenerative arthritis.
4. Hyalex Orthopaedics earned FDA investigational device exemption for its Freestyle knee implant, opening up the door for clinical trials.
5. Orthopedic implant company BioPoly secured FDA approval for its new knee implant.

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