Back to Blog

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

Formus Labs, a Pioneering Developer of Orthopedic Surgery Planning Technology, Hires Ex-Johnson & Johnson Executive, Polly Teevan, To Lead Global Commercial Strategy

Formus Labs, creator of the world's first fully-automated 3D planner for joint replacement surgeries, today announced it has hired Polly Teevan as Chief Marketing Officer. Teevan will oversee global commercial and marketing strategy, and lead Formus to expand its presence in the US and international markets leveraging her deep customer relationships, industry knowledge and commercial experience.

Read Story

Formus Labs Adds Seasoned Medical Technology Executives Lloyd McCann and Meraj Khan to Board of Directors

Formus Labs, creator of the world's first fully-automated 3D planner for joint replacement surgeries, today announced the appointments of Mercy Radiology and Clinics CEO, Dr Lloyd McCann, and Vice President of Market Development at BK Medical, Meraj Khan, to its Board of Directors. Each brings more than 15 years of international medical technology and healthcare experience in a variety of roles.

Read Story

Formus Labs Raises $5 Million to Automate Orthopedic Surgery Planning; Partners With Zimmer Biomet to Supercharge Global Launch

Formus combines AI and biomechanics to empower orthopedic surgeons with fully interactive 3D models to optimize the preoperative planning process

Read Story

Subscribe for the latest news and product updates

We will never share your email address with third parties.