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The indications for Biomet's Ascent™ Porous Open Box PS Femoral Component include:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis, where one or more compartments are involved.
2. Correction of varus, valgus or posttraumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

The Ascent™ Porous Open Box PS Femoral Component is a metallic knee femoral component to be used with Biomet's Ascent™ tibial base-plate components. The device also includes distal femoral pegs. The modular pegs are designed to fasten into the existing distal augment holes of the femoral component and act as alignment devices. The device is manufactured of CoCrMo Alloy and is intended for non-cemented use. The components are identical to those cleared in the previous 510(k) submission (K002678) for cemented application.

The provided text is a 510(k) summary for the Ascent™ Porous Open Box PS Femoral Component. It describes the device, its intended use, indications for use, and claims substantial equivalence to previously marketed devices. However, it explicitly states:

"Clinical and Non-Clinical Testing: None provided"

Therefore, there is no information in this document regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

In summary, the document does not contain the information requested in your prompt.

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