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The US Food and Drug Administration (FDA) has granted 510(k) clearance for Surgical Planning Associates’ new HipInsight 2.0 mixed-reality guidance system intended for hip arthroplasty.
The patient-specific mixed-reality technology includes advanced features designed to facilitate both primary and complex revision arthroplasty procedures.
It allows surgeons to visualise three-dimensional information in and around the hip joint, akin to having ‘X-ray vision’.
The technology now supports a new patented way of overlaying digital material on the patient, making workflow more versatile, smooth, and adaptable to any surgical procedure.
Traditionally, surgeons must undertake three-dimensional surgical procedures using two-dimensional X-ray planning and, in many cases, intraoperative X-ray evaluation.
The HipInsight technology displays three-dimensional information on mixed-reality display eyeglass lenses, providing surgeons with a more intuitive understanding and allowing them to focus on the patient.
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By GlobalDataIt also offers the option to generate ‘future X-rays’ that predict the surgical outcome, which can be projected onto actual intraoperative X-rays for a live comparison during the procedure.
Additionally, the HipInsight system has introduced a new capability for the rapid assessment of leg length and change in hip width.
Based in the US, Surgical Planning Associates offers preoperative planning and navigation solutions for joint arthroplasty.
The company has a multi-year co-marketing deal in place with ZimmerBiomet Holdings for the HipInsight System.
ZimmerBiomet marketing vice-president Steve Vankoski said: “Our companies have been able to work synergistically through our exclusive collaboration to successfully support the clinical use of this fast-evolving, transformative technology.”
In 2021, Surgical Planning Associates introduced its HipInsight augmented reality (AR) intra-operative guidance system for joint arthroplasty.