Providence Medical Technology Inc. (PMT), a private corporation focused on developing minimally invasive technologies, has received the FDA’s 510(k) clearance to market PMT Bone Screws in the U.S. “This clearance represents an important step in broadening our posterior cervical platform of single use disposable instruments and implants, ” said CEO Jeff Smith. “Posterior indirect decompression and fusion provides a compelling minimally-invasive alternative for patients suffering from cervical radiculopathy.”
Providence Medical Lands Key FDA Clearance
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Company officials indicated that the PMT Bone Screws are for single use only in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device.
Providence’s posterior cervical platform now consists of DTRAX Graft, DTRAX Cervical System, and PMT Bone Screws in the U.S., and the DTRAX Facet System outside of the U.S. The company is finalizing manufacturing plans for the PMT Bone Screws and related delivery systems, and anticipates full market release during the first half of 2013.
“I am encouraged by our team’s ability to develop new products and gain necessary regulatory clearances to support our growing DTRAX platform, ” said Smith. “We launched two new products in the U.S. in 2012, and anticipate two additional products in 2013.”
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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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