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 Simplicit 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.
Arthrex, DePuy Synthes, DJO, Integra LifeSciences and Stryker could be interested in stemless devices to bolster their U.S. shoulder portfolios. Several companies offer stemless shoulders in European markets, including Arthrex, Arthrosurface, DePuy Synthes, and Mathys. Zimmer Biomet’s Sidus and Wright Medical’s Simpliciti have been on the European market since 2011 and 2012, respectively.
Speaking of competition, the entrance of Equinoxe and Sidus to the U.S. market could reduce Wright Medical’s U.S. upper extremities growth in 2H18 and 2019.
Equinoxe is accompanied by a single instrument tray to support O.R. efficiency, and features a 3D porous structure and bone cage to enhance biologic fixation. The Equinoxe line, first launched in 2004, includes components for primary, revision, reverse, fracture, resurfacing, etc. Shoulders account for about 40% of Exactech’s total sales, or $120MM.
Shoulders are the most frequently replaced extremity—53,000 Americans have shoulder replacement surgery every year, compared with 900,000 who undergo hip or knee replacement surgery annually, according to the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services.
Anatomic implants, which include stemless shoulders, are the most-widely-used shoulder prosthesis. Approved in the U.S. in 2014, stemless shoulders are considered less invasive than traditional shoulder implants, as they minimize bone removal and soft-tissue disruption. This makes them more of an attractive option for younger patients. Part of the draw of stemless shoulders for these patients is minimal alteration to an active lifestyle.
*Images courtesy of Exactech