After an intensely detailed application process, we submitted our 510(k) pre-market approval for FDA clearance for the Formus Hip product last month. By using an FDA-certified third-party reviewer for our application, we expect to receive a quickened response by May this year.
While this application shows the safety and efficacy of the Formus Hip product, the submission included details on the Formus platform which forms the basis for all products developed by Formus Labs. This additional information provided will expedite the review process for future product clearances from the FDA.
Having FDA approval will give Formus Labs access to the US market, in which there are more than 450,000 hip surgeries performed per year. This will also pave the way for subsequent Formus Labs’ products to receive swift acceptance to service the more than 1.5 million joint replacement surgeries per year in the US.
“Submitting an application to the FDA is a huge milestone for any medical device company, let alone a New Zealand medical device company. Our team has done a lot of great work getting to this point. Anticipation levels are high, from both us and our users, as we wait for a response. I am proud of our team for reaching this achievement,” says CEO Dr Ju Zhang.