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Reverse total shoulder arthroplasty – is its current use consistent with FDA's "Indications for Use"?


The Federal Drug Administration oversees approval of new drugs or devices for use by patients in the United States. It defines the Indications for Use before identifying the product with these indications. 

In late 2003, the FDA approved the first reverse total shoulder surgery (rTSA), for use in the United States (Delta Shoulder, K021478; DePuy Inc. Raynham, MA USA). The FDA approved on-label Indications for Use for rTSA at that time were limited to cuff tear arthropathy and revision surgery: “Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. 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” (see shoulder prosthesis, reverse configuration and FDA clearance).
Following the approval of rTSA use in rotator cuff injury arthropathy, surgeons started to use rTSA off-label (i.e. Other than the approved indications, such as osteoarthritis and rotator cuff tears, massive cuff injury without osteoarthritis, and tumor, inflammatory arthritis, these are all possible uses for rTSA.

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