Zimmer Biomet Holdings, Inc. receives a lot of FDA clearances each year. The company does not usually issue press releases for each clearance.
FDA Clears Zimmer Biomet’s Stem-Free Shoulder
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But on January 3, 2018, the new CEO of the company, Bryan Hanson, announced the FDA 510(k) clearance of the Sidus Stem-Free Shoulder system. The system is a total shoulder arthroplasty solution “for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.”
The system, says the company, is designed to “anatomically restore a patient’s anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes.”
According to the company’s British website, the humeral component is positioned independent to the location of the humeral canal, enabling optimal coverage and placement. Eleven humeral head options allow for patient-matching flexibility. The system also has the flexibility to mate with either Anatomical Shoulder Glenoids or Bigliani Flatow Glenoids, including the Trabecular Metal Glenoid.
Ryan Krupp, M.D., an orthopedic surgeon at Norton Orthopedic Specialists in Louisville, Kentucky, said the system is offers a “novel approach to total shoulder arthroplasty requiring minimal bone resection.” He added that the system is designed to reduce pain and restore range of motion and is “clinically proven to help suitable patients.”
Hanson said the clearance comes at a time when Zimmer Biomet is “accelerating the pace of innovation.” He noted the Sidus was launched in Europe in 2012 and a clinical study was initiated in the U.S. in 2015. “During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet’s U.S. portfolio reinforces the company’s leadership in the innovation of shoulder solutions.”
The company submitted the clearance notification in June 2017 and the clearance decision was made in December.
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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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