Pixee Medical Receives FDA Clearance for Knee+

  • Digitally augmented surgeons are to become a reality in the USA
  • Focus on total knee arthroplasty in ambulatory surgery centers

April 28, 2021

BESANCON, France–(BUSINESS WIRE)–Pixee Medical, a pioneer in digitally augmented surgery technology, announces that its Knee+ AR computer assisted orthopedic solution has received 510(k) clearance from the U.S. Food and Drug Administration.

Kneeis a patented platform designed to assist orthopedic surgeons to perform surgeries better and faster by providing real-time positioning of instruments, right in their field of view. Knee+ is intuitive and requires minimal training since it does not change the overall technique for 90% of surgeons who use a conventional technique but have never utilized navigation or robots. Kneeconsists in a proprietary software using unique computer vision and artificial intelligence algorithms and running on connected smartglasses, with no bulky capital equipment or disposables required.

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The first Knee+ surgery was performed in June 2020 in Lariboisière Hospital in Paris. Pixee Medical began commercialization in Europe and Australia in January 2021 and was surprised by just how quickly its product was adopted, with more than 60 systems sold in Q1. The company proved that the market was ready for this innovation and is now expanding rapidly by partnering with leading orthopedic implant companies.

“The FDA’s clearance of Knee+ is an important step forward as the USA represents 50% of the worldwide market. We plan to quickly expand our platform to perform hip and shoulder replacements” states Sébastien Henry, Founder and CEO of Pixee Medical. “In addition, our platform is designed to become the cornerstone of data acquisition and exchange during surgery as well as a plug-and-play hub for accessories like connected instruments, robotic arms and wireless tools.”

“Today, Knee+ is well positioned to help ambulatory surgical centers face the significant backlog and increase in knee surgery. These centers need intuitive, effective, attractive and affordable solutions to meet their patients’ needs, now.”

About Pixee Medical

Pixee Medical’s ambition is to empower all orthopedic surgeons with the latest breakthrough in precision surgery, to become digitally augmented surgeons. Learning from the success, as well as the challenges of adopting navigation and robotized approaches, Pixee Medical developed its surgeon-centric platform with the belief that all surgeons deserve intuitive tools to augment their knee, hip and shoulder replacement surgeries, without facing hurdles in terms of capital equipment, changing techniques, training, additional staff or longer procedure times. Pixee Medical’s augmented surgery platform is commercially available in Europe, Australia, and the USA for total knee arthroplasty with Knee+.


Media Contact information:
Charlotte Beck

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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