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• Advanced Joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
• Fracture or avascular necrosis of the femoral head.
• Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

The Protek Low Profile Acetabular Cup (Catalog No. ) is fabricated from ultra molecular high weight polyethylene (UHMWPE) . . The Protek Low Low Low Profile Acetabular Cup is spherical in design and employs longitudinal cement channels and circumferential cement grooves along the outer surface of the cup. The longitudinal cement channels and vertical grooves provides greater cement interdigitation with PMMA bone cement. addition, the Protek Low Profile in Acetabular Cup employs radiographic marker wires along the periphery of the outer rim and on the superior outer portion of the acetabular cup. smaller sizes of the Protek The LOW Profile Acetabular Cup [Sizes 22mm (ODs' 36, 38, and 40mm), 28mm (OD 42mm), and 32mm (ODs' of 44 and 46mm)], with a minimum polyethylene thickness of 6mm are intended only for use with the Protek acetabular reinforcement devices which are utilized in patients with acetabular bone deficiencies. The Protek acetabular reinforcement devices have been determined substantially equivalent by the FDA via 510 (k) #K953578. The Protek Low Profile Acetabular Cup is available in inner diameters of 22, 28, and 32mm, with outer diameter sizes ranging from 36 to 64mm with -2mm increments. The Protek Low Profile Acetabular Cup, like the predicate acetabular components, is intended for cemented fixation within the prepared acetabulum.

This document is a 510(k) Premarket Notification Summary for a medical device, specifically an acetabular cup for total hip replacement. The purpose of this summary is to demonstrate substantial equivalence to previously marketed devices, not to present a study proving the device meets specific acceptance criteria through clinical trials or performance metrics.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or statistical performance data.

The document focuses on comparing the "Protek Low Profile Acetabular Cup" to predicate devices (already legally marketed) based on:

1. Materials: Both the subject device and predicate devices are made from ultra high molecular weight polyethylene (UHMWPE).
2. Intended Use: Both the subject device and predicate devices are intended for cemented application in total hip replacement for similar indications (e.g., advanced joint destruction, fracture, failed previous surgeries).
3. Design Characteristics: Both are spherical in design and employ longitudinal cement channels.

The concept of "acceptance criteria" in this context refers to demonstrating substantial equivalence, which is assessed qualitatively against predicate devices, not through a quantitative performance study with predefined statistical targets. There are no reported device performance metrics, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because this type of premarket notification does not typically involve such studies for demonstrating equivalency of a Class II device of this nature.

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