Tornier N.V. (Amsterdam, The Netherlands), an orthopedic surgical solutions company, has announced the first implant of its Simpliciti stemless shoulder joint replacement system as part of an FDA -approved, investigational device exemption (IDE) study. The Simpliciti system is designed to allow surgeons to carry out total shoulder replacements without the complications, additional bone removal and time associated with conventional stemmed implants.
The trial represents the first multi-center, prospective FDA-approved clinical trial for a stemless shoulder prosthesis. Tornier plans to enroll 157 patients who will be followed for two years. The Simpliciti system received CE marking clearance in February and was commercially launched in Europe at the beginning of June.
Press release: Tornier Announces First Implant in U.S. Clinical Study for the Simpliciti™ Stemless Shoulder Joint Replacement System…
Product page: Simpliciti…