FDA 510(k) clearance for our pre-operative planning software Customize for shoulder and ankle arthroplasty
This customisation is applicable to a wide range of medical and surgical applications: shoulder, knee, ankle or any other joint in the body.
The Customize web-platform has been set up to create turnkey solutions for various arthroplasties. Customize for Arthroplasty is an advanced web-based 3D planning system that allows interactive, fast and accurate selection and placement of an implant on the patient’s anatomy and connects to tools to transfer the planning in the operating theatre. It can be used on a wide range of anatomies: shoulder, knee, ankle, hip or any other joint in the body. Customize for Arthroplasty already received 510(k) clearance for the shoulder and ankle anatomies.
A 3D planning is performed based on CT scan images of the patient. After a medical segmentation of the bony structures, 3D reconstructions are performed. A 3D planning is then produced to draft implant positioning, size and type. The surgeon can adapt or validate the proposed planning online while checking various scoring (inclination, coverage, perforation,…) and 2D information on the initial DICOM.
Patient-specific instruments - optional
Based on the 3D planning, patient-specific instruments are designed and manufactured. PSIs can be used during the surgery to guide the surgeon’s hand during the drilling/cutting, providing a fast and accurate realization of the planning.
Various technologies can be incorporated into the planning to guide the surgeon during the surgery: robotic system, navigation, augmented reality,…
Applicable to the whole body
The AI engine can be activated to improve the quality of service (immediate segmentation or planning proposal to the surgeon).
Customize platform integrates communication, interactive pre-op planning, design and production management tools, optimizing the entire process of 3D surgical planning and production of patient-specific medical devices. It has been built over years with the experience of 3D-Side for its own patient-specific products. Web-based, Customize is accessible everywhere, from any device.
Our segmentation engine has been developed over many years. It is adaptable to the customer's application to allow AI-based segmentation
Customize is not a “one-size-fits-all” solution. Each medical manufacturer receives a customized and customizable platform tailored to its own needs, look & feel, custom application, specific processes and workflow, personal communication, etc., all in a single online software.
Planning outputs can be injected into any intraoperative technology (surgical guide, robotics, navigation, augmented reality…). The solution adapts to the needs and regulatory status.
The result of the 3D planning can be exported to various intraoperative technologies to guide the surgeon: surgical guide, robotics, navigation, augmented reality…. Our customers can have a unique platform but send the result to specific technologies according to the surgeon's request.
This advanced interface is connected to other Customize modules, offering collaborative medicine, short lead time and unprecedented customer experience.
Customize integrates communication, design and production management tools, optimizing the entire process of 3D surgical planning and production of anatomical models & patient-specific medical devices.
Its main goals: interact online with doctors, create patient-specific models, custom-made devices and supervise the global custom process. The results are impressive: zero waste of time in communication, lead times reduced up to 10 times, and 100% automatic traceability to meet regulatory requirements.
The platform is not a “one-size-fits-all” solution but is customizable to fit each customer’s needs. Each platform is unique and available online. Each institution receives one specific platform with their own branding, developed to fit their custom applications and gather all data, workflows & communication into one single online software.
Customize is a class IIa CE marked software for Europe and is also US- certified.