Fact checked byGina Brockenbrough, MA

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September 06, 2024
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Surgical Planning Associates receives FDA 510(k) clearance for mixed-reality THA system

Fact checked byGina Brockenbrough, MA
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Key takeaways:

  • Surgical Planning Associates announced it received FDA clearance of the HipInsight system 2.0.
  • The mixed-reality surgical guidance platform utilizes 3D surgical guidance for total hip arthroplasty procedures.

Surgical Planning Associates announced it received FDA 510(k) clearance of its HipInsight system 2.0, a mixed reality surgical guidance platform for total hip arthroplasty, according to a company press release.

The HipInsight system 2.0 utilizes mixed-reality display eyeglasses, which allow surgeons to visualize 3D surgical guidance information while performing primary or revision THA procedures, according to the release.

Hip replacement
Surgical Planning Associates announced it received FDA clearance of the HipInsight system 2.0. Image: Adobe Stock

“Every patient's anatomy and hip arthritis is unique,” Matthew D. Miller, MD, arthritis and joint replacement surgeon at Stanford Health Care and El Camino Health, said in the release. “HipInsight allows a customized 3D model that helps a surgeon plan for and execute a more perfect reconstruction for each individual patient.”

The system will be marketed through a multi-year co-marketing agreement between Surgical Planning Associates and Zimmer Biomet, which was announced in 2022.

“Our companies have been able to work synergistically through our exclusive collaboration to successfully support clinical use of this fast-evolving, transformative technology,” Steve Vankoski, vice president of marketing at Zimmer Biomet, said in the release.

Reference:

https://investor.zimmerbiomet.com/news-and-events/news/2022/09-01-2022-120156031