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The Univers Revers CA humeral head and adapters are indicated for:
• salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed
humeral stem, to an anatomic hemi-shoulder replacement; or
• conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator
cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement
when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has
been implanted.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and
a functional deltoid muscle is necessary to use the device.

The subject device is a line extension to the Arthrex Univers Revers CA Heads and Adapters cleared in
K151527. The subject device components are smaller and are made of the same materials (cobalt
chromium, titanium, and UHMWPE) as the predicate. The subject devices are designed for use with the
Arthrex implantable devices cleared in K221232, K230366, K161782, K142863 and K170414. The
subject devices are labeled with MRI conditional claims in accordance with Arthrex labeling cleared
under K230513.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study as the provided text does not contain information about an AI/ML device or software. The document is an FDA 510(k) clearance letter for a medical device called "Univers Revers CA Head and Adapter," which is a shoulder prosthesis. The performance data section refers to mechanical and biocompatibility testing, not AI/ML algorithm performance.

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