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3D-Side Gains 510(k) for Ankle Arthroplasty Pre-Operative Planning

Updated: Sep 16, 2022

After receiving a 510(k) clearance for its fully automated radiological image processing software, Customize, and its pre-operative planning for shoulder arthroplasty earlier this year, 3D-Side now received 510(k) clearance for ankle arthroplasty solutions. With this new 510(k) clearance, Customize is now intended to be used for the pre-operative planning of ankle arthroplasties.

Customize displays surgical planning options that are created based on 3D CAD files, generated from multi-slice DICOM data and X-RAY-based information, using Artificial Intelligence during the segmentation process.

The web-based platform allows physicians to review a 3D pre-operative planning of the reconstruction of the ankle pathology.

Customize includes implant libraries, providing the ability to achieve ideal positioning, sizing, and orientation of talus and tibia components based on physician’s input.

After physician's approval, the final plan is saved and can be used as a reference during surgery.

Customers are currently being onboarded with this new pre-operative software, for an official launch expected in Q3 2022.


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