Search Results

The Trident® Large Diameter Acetabular Inserts are intended for the replacement of the bearing and articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.

These subject devices are provided sterile and designed for single use only, and are intended for use in patients indicated for total hip arthroplasty. The components may be used for primary and revision applications.

Indications for Use:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

The proposed acetabular inserts are Ultra High Molecular Weight polyethylene devices that range thickness from 3.8mm to 12.6mm measured at 34° from the axis of symmetry. The subject inserts include Trident® Large Diameter acetabular inserts, which will be available in 40mm and 44mm inner diameter (ID), and accommodate Howmedica Osteonics' 40mm and 44mm cobalt chrome femoral heads (K061434). The sizes 28 through 36 inner diameter inserts accommodate previously cleared Howmedica Osteonics' femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Trident® Large Diameter Acetabular Inserts. The document is a 510(k) summary, which focuses on the regulatory aspects of the device, its intended use, indications for use, and substantial equivalence to previously cleared devices. It does not include data from performance studies or clinical trials describing acceptance criteria and how a device met them.

Ask a specific question about this device