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Formus Hip 510(k) FDA Submission

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.

More from the Lab

X-ray Analysis

Formus Labs software engineer Jamie Kydd started developing this technology in late 2020. Jamie says the software has the potential to allow surgeons to know how accurate their surgeries have been. 

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New Clinical Hire

With the support of Callaghan Innovation, Formus Labs has recently hired a Clinical Research Associate. Lilian Lim came to Formus Labs from a year as a research assistant with the Musculoskeletal Modelling Group at the Auckland Bioengineering Institute (ABI) after completing her Masters of Engineering in 2020.

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First Australian Hire

Formus Labs has recently hired Zoe Hart as their Australian Country Manager. Zoe is the company’s first representative in Australia. She will lead business development, marketing/sales strategies and build the name of Formus Labs, helping to bring more surgeons on board and support the sales team of our commercial partner. 

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