Polaris AR receives FDA 510(k) clearance for mixed reality TKA guidance system
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Key takeaways:
- Polaris AR received FDA 510(k) clearance of its Stellar Knee, a mixed reality guidance system for TKA procedures.
- The system provides surgeons with real-time data to aid intraoperative planning.
Polaris AR has announced FDA 510(k) clearance of its Stellar Knee system, a mixed reality guidance system for use during total knee arthroplasty procedures, according to a company press release.
The Stellar Knee system uses optical tracking algorithms and spatial computing software to provide surgeons with a holographic display of real-time data on hard and soft tissue anatomy, resection guidance and accuracy and intraoperative planning. The system is projected through a headset, according to the release.
“Our software has the capacity to usher in the next generation of surgical advancements. This is a new day for orthopedics, and surgery as a whole, because the promise of augmented reality is now being fulfilled,” Paul Mikus, CEO of Polaris AR, said in the release. “Stellar Knee is pioneering a new class of surgical software that utilizes best in class spatial computing and optimizes operating room workflow.
“Stellar Knee not only impacts the surgeon and the patient, but also empowers health care providers to change the standard of care,” Mikus added.
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