{"id":26829,"date":"2021-01-21T00:05:49","date_gmt":"2021-01-21T00:05:49","guid":{"rendered":"https:\/\/www.3dnatives.com\/en\/?p=26829"},"modified":"2021-01-20T17:49:53","modified_gmt":"2021-01-20T17:49:53","slug":"adam-3d-printed-personalizable-bone-implants-210120214","status":"publish","type":"post","link":"https:\/\/www.3dnatives.com\/en\/adam-3d-printed-personalizable-bone-implants-210120214\/","title":{"rendered":"A.D.A.M project develops 3D printed personalizable bone implants platform"},"content":{"rendered":"

Founded in 2018 by 3D printing company Kwambio and WeFund Ventures in Ukraine, ADAM develops on-demand 3D printed bone implants<\/a>. The initial vision of the company was to create a carshop-like infrastructure where any part of the human body could be treated like a replaceable part. In the end, the ADAM team decided to start the development of the project with a focus on bone implants. They developed proprietary 3D printing technology and material composites for these implants (biopolymer and bioceramic materials). They revealed that the first prototypes passed pre-clinical trials in wistar rats.<\/p>\n

The solution imagined by ADAM aims to facilitate the surgical planning process. In fact, AM is increasingly being integrated in clinician’s routine<\/a> to evaluate and develop solutions for patients that are quick, tailor-made and cost-effective. Therefore, patients can upload and securely store their MRI and CAT scans on ADAM’s digital platform. When the patient is in need of a bone implant, certified clinicians are able to use the platform to create a 3D model of the implant based directly on the patient’s medical data.<\/p>\n

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Image taken from Youtube video<\/a><\/p><\/div>\n

The 3D model of the patient-specific bone implant can then be used for production, using proprietary 3D printers. Printing can take place at ADAM or directly on-site, according to preference. Production takes about 24 hours, which is substantially faster compared to existing alternatives. The material composites used also result in a lower cost of production than for titanium or PEEK-based implants.<\/p>

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Today, the ADAM team explained that successful results of the trials allowed it to file the Q-Submission to the FDA. The FDA\u2019s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. In their response, the FDA confirmed ADAM biopolymer and bioceramic bone implants’ 510(k) eligibility – 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.<\/p>\n