The FDA is still clearing medical devices. On May 1, 2020, the agency granted 510(k) clearance for Corin USA’s OPSInsight, a cloud-based software which brings the company’s Optimized Positioning System (OPS) online.
Corin Hip Replacement Software Cleared
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#hiparthroplastySecondary#corin#optimizedpositioningsoftware
According to a May 12, 2020 company announcement, the software enables surgeons to access and adjust customized pre-operative plans for total hip arthroplasty (THA). “This interactive planning solution is the latest evolution of Corin’s Optimized Positioning System, which uses pre-operative functional imaging to enable surgeons to precisely plan optimal implant alignment, considering individual patient anatomy, spinopelvic mobility and functional biomechanics.”
Surgeons are also able to access additional information, “including advanced spinopelvic assessment, impingement analysis and radiodensity mapping. This level of insight is significant in providing implant placement that is personalised for each patient’s needs.”
Optimized Positioning System (OPS)
The OPS system was originally cleared in June 2016 and, according to the FDA clearance documents, is intended to be used as a “patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty,” and “intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X-rays and CT imaging scans.”
The system consists of software and hardware components and is intended for use with direct anterior or posterolateral surgical approaches and the guides are intended for single use only.
Jim Pierrepont, Ph.D., the company’s chief innovation officer, said he and his colleagues believe that OPSInsight “is the new gold standard in THA planning. The possible depth of analysis is unparalleled, and key insights are presented in an intuitive and user-friendly interface to our surgeons. We believe this level of planning is a necessity to improve outcomes in THA.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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