Search Results

The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.

The PE-PLUS Acetabular Cup is made of an ultra high molecular weight polyethylene (ASTM F 648) and accommodates three ball head sizes (diameters of 22, 28, and 32). Twelve sizes are available for the 22 and 28 head diameters, (cup sizes 42 to 64, in 2mm increments) and nine cup sizes for the 32 head diameter (cup sizes 48 to 64, in 2mm increments).

The provided text describes a 510(k) submission for a medical device called the "PE-PLUS Acetabular Cup." This submission primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided text.

Specifically, the document states:

• "Extensive literature has been provided." This indicates that the submission relies on existing published information, likely related to the predicate devices or general principles of joint arthroplasty materials, rather than new, primary performance data for this specific device.
• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This confirms that the approval is based on substantial equivalence, not on the demonstration of specific performance criteria through a dedicated study.

Given this, I cannot provide the requested table or detailed study information as it is not contained within the provided document.

Ask a specific question about this device