It is clear that the reverse total shoulders (rTSA) represent a significant technological advancement for patients with complex shoulder disorders. The number reverse total shoulder implants is rapidly increasing due to the fact that (1) more surgeons use it, (2) older and younger patients are treated with it, and (3) a wide range of shoulder conditions can be treated.
Here are some comments about recent articles that relate to the rTSA.
FDA clearnance
Federal Drug Administration (FDA), in the United States, cleared the reverse total shoulder for use twenty years ago. The FDA has the authority for approving use of orthopaedic implants by the 510(k) “clearance” mechanism, which bypasses the clinical trials required by the PreMarket Approval pathway which is used to assure the safety and efficacy of new medications (see How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants? ).
Please note that the FDA cleared the reverse total-shoulder device under 510(k), based on its being “substantially similar” to another device.
Then, anatomic The FDA had previously cleared total shoulder surgery.
