Blue Belt Technologies, Inc., after a bruising marketing squabble with MAKO Surgical Corp., announced on June 4, 2013 that the FDA has granted 510(k) clearance to market its Stride Unicondylar knee implant system.
Blue Belt’s Knee Implant Cleared by FDA
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The company said the implant system will be co-marketed with Blue Belt Technologies’ NavioPFS precision orthopedic surgical system which has been commercially available in the U.S. since December 2012.
Company President and CEO Eric Timko said the company remains “focused and committed to continuing to build out NavioPFS’s open architecture for implant selection. Allowing our customers to adopt technology while continuing to maintain their long-term existing relationships with implant manufacturers will allow Blue Belt to reach a wider physician audience.”
Jess Lonner, M.D., attending orthopedic surgeon at the Rothman Institute in Philadelphia added, “Stride’s optimized aspect ratios, implant design and size offerings will reduce the need for compromise and enhance functional and clinical outcomes. Additionally, its geometry interfaces well with NavioPFS to allow efficient and accurate bone preparation.”
The system is available for treatment of both medial and lateral compartment osteoarthritis. The company expects to begin marketing the system immediately.
Blue Belt is developing surgical instruments for use initially in orthopedic procedures and then for other surgical specialties, including neurosurgery, spinal and otolaryngology (“ENT”). The company’s NavioPFS system incorporates patented technology to provide control to surgeons via a handheld, computer assisted bone cutting tool.
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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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