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U.S. Spine and Trauma Markets Gain New Entrants

By Julie A. Vetalice

Spine, trauma, spine, trauma—these two segments are leading FDA 510(k)s this year. In looking at recent clearances, I’m compelled to highlight these segments in part due to Globus Medical's activity. Globus (a ~$565MM company) has received clearance for its first two non-spinal trauma products. Seeking to diversify outside of spine, the company plans to derive 15% of its revenue from trauma and robotics by 2020. In Globus’ 2Q17 earnings call, leadership affirmed that several trauma products planned for 2017 had received FDA clearance and were in full production mode. Later in the call, it was mentioned that they are about halfway through their core bag in terms of FDA clearances, so perhaps this is an indication of four trauma products initially, from Globus. I will keep you apprised.

Meanwhile, the continual entry of new companies into the U.S. spine and trauma markets does not come as a surprise, and frankly is expected to continue. Spine and trauma, the second and third largest orthopaedic market segments respectively, have not faced the same level of hospital scrutiny as the hip and knee segments. In the link below, I present new spine products from EIT Emerging Implant Technologies, HD LifeSciences and Osseus Fusion Systems, and new trauma products from Globus Medical and HNM Total Recon/HNM Medical. I chose these from the list of recent 510(k) clearances primarily because, except for Globus and Osseus, they’re new entrants to the U.S.

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