3D Systems announces FDA provided clearance for TOTAL ANKLE

3D Systems announced the Food and Drug Administration, FDA, has provided 510(k) clearance for TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew’s SALTO TALARIS Total Ankle Prosthesis and CADENCE Total Ankle System. The products feature individualized pre-surgical planning and a patient-specific 3D-printed instrument set that ensures accurate implant alignment and sizing for tailored total ankle replacement surgery. The collaboration between 3D Systems and Smith+Nephew, the global medical technology company, achieved these patient-matched solutions that enable surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper function of the ankle joint. These patient-matched guides are engineered and manufactured using 3D Systems’ VSP surgical planning solutions that combine best-in-class digital workflows with the industry’s broadest additive manufacturing portfolio of printers and materials.