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The device is composed of a metallic humeral stem which is designed to articulate with a commercially available glenoid component. There is no linkage across the joint.

The tapered collarless stem follows the natural contours of the canal; the tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. Proximal fins contribute to maximize rotational stablity while suture holes in the fins allows for proximal reconstruction of complex humeral fractures. The stem is "grit blasted" for a roughened surface of 200 microinches which provides for an improved fixation between the stem/coment interface.

Stems are available in 7 sizes with diameters ranging from 6.5mm to 15.5mm in 1.5mm increments at a length of 115mm. for primary use. Revision stems are available in a range of diameters of 8.0mm to 1.5mm increments at a lenath of 190mm.

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for an AI device.

The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device called the "CoCr Bi-Angular Humeral Component," which is a shoulder joint prosthesis. It describes the device, its potential risks, and lists commercially available equivalent devices. It also includes a table of reported complications associated with total shoulder arthroplasty, citing various medical literature.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.

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