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Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

By Rob Meyer

New stemless (also referred to as stem-free or short stem) shoulder competition could be a significant growth driver for companies’ upper extremities portfolios.

This is the sentiment from industry analysts following the recent announcement of FDA 510(k) clearance for Exactech’s Equinoxe® stemless shoulder. Equinoxe—a bone- and canal-sparing implant for total shoulder arthroplasty—has entered limited launch, with expanded release slated for 2H18.

Equinoxe is seen as direct competition to Zimmer Biomet’s Sidus®—which launched in 1Q18—and Wright Medical’s Simpliciti®. The three represent the only FDA-cleared stemless shoulders on the U.S. market.

Though stemless shoulders are relatively new, several analysts, including Larry Biegelsen of Wells Fargo Securities, noted that the FDA clearance of the Equinoxe “will continue to grow the category.”

Of significance with this Exactech clearance is that, according to analysts, it was done without an Investigational Device Exemption (IDE), which allows a device to be used in a clinical study in order to collect safety and effectiveness data. Both Sidus and Simpliciti were cleared by FDA with IDEs. Biegelsen notes that if FDA no longer requires IDEs for stemless shoulders, the agency could allow other manufacturers to enter the market faster than anticipated—in about one year, following Exactech’s timeline for Equinoxe.

For more on the stemless shoulder, read more at BONEZONE®

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