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3D-Side received another 510k clearance

Updated: Jul 19, 2022

3D-Side received another 510k clearance for its pre-operative planning software Customize for shoulder arthroplasty.

This particular clearance allows physicians to use the processing software to pre-plan shoulder arthroplasty surgeries

Customize is intended to be used during the preparation of shoulder arthroplasties for adult patients only. It displays surgical treatment options that are created based on 3D CAD files generated from multi-slice DICOM data from a CT scanner and uses Artificial Intelligence during the segmentation process.

It is a web-based platform where the physician can review the CAD files in 3D and modify the position and orientation of the different 3D objects. Customize includes an implant library with 3D digital representations of various implant models so that the ideal implant positioning and sizing can be achieved based on the physician’s input.

After physician approval, the treatment plan is saved on the server and can be used as a reference during surgery.

The first customer being onboarded to this new pre-operative planning software is Catalyst OrthoScience with its platform named ArcherTM 3D Targeting.

3D-Side plans to submit another 510(k)s for ankle joint replacement in the near future.


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