Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components. Final order.

The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Reverse total shoulder arthroplasty for the management of fractures of the proximal humerus: a systematic review.

Reverse total shoulder arthroplasty (RTSA) represents a good solution for the management of patients with fracture of the proximal humerus with associated severe osteoporosis and RC dysfunction. A systematic review of the literature according to the PRISMA guidelines was performed matching the following keywords: "reverse total shoulder arthroplasty"; "reverse total shoulder prostheses"; "fractures"; "fracture of the proximal humerus." Medline, EMBASE, Google Scholar, and Ovid database have been screened. Ten studies were considered in the qualitative analysis. No randomized prospective controlled trials have been found. A total of 256 patients received a RTSA for the management of fracture of the proximal humerus. There were 28 males (10.8 %) and 228 females (89.2 %). The mean age of patients was 75.5 ± 2.2 years (range 70-78 years). The mean follow-up period was 27.8 ± 21.8 months range (6-86 months). Overall, the mean Constant score was 56.7 ± 7.6 points (range 44-67.8 points), the mean DASH score was 39.9 ± 6 points (range 31.5-46.8 points), the ASES averaged 70.3 ± 6.8 points (range 65-78 points), and the OSS averaged 28.7 points (range 15-56 points). RTSA restores function and relieves pain in patients with proximal humeral fractures. However, no randomized controlled trials are available to support RTSA versus osteosintesis, anatomical prostheses or hemiarthroprotesis. Further studies are needed to evaluate the effectiveness of RTSA in the management of fracture of the proximal humerus.