Exactech wins FDA nod for Equinoxe stemless shoulder
Exactech wins FDA nod for Equinoxe stemless shoulder

Exactech (NSDQ:EXAC) said yesterday it won FDA clearance for its Equinoxe stemless shoulder prosthesis designed to be compatible for use with the Equinoxe shoulder system.

The Gainesville, Fla.-based company said the system is designed for anatomic total shoulder arthroplasty procedures and features a 3D porous structure and an incorporated bone cage for bone through-growth to increase biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market. Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology,” design team member Dr. Buddy Savoie III of Tulane University said in a prepared statement.

Exactech said it plans to launch a clinical study of the Stemless Shoulder immediately, and that it aims to “aggressively expand” the release of the device during the second half of this year.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly and is emblematic of our mission to help patients,” Exactech extremities marketing VP Darin Johnson said in a press release.

Last month, Exactech announced the closing of its $737 million go-private sale to TPG Capital, with TPG acquiring all issued and outstanding stock of the company.

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