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Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.

The HA X-Series Bi-Metric® Hip Femoral Components consist of the same design and materials as the predicate devices contained in 510(k) K020580 except that the stems have been further coated with hydroxyapatitie (HA) coating. The HA coating has been added to enhance tissue adherence.

This document describes a 510(k) premarket notification for a medical device, the HA X-Series Bi-Metric® Hip Femoral Components. The application states that no clinical testing was provided for this device, as it is substantially equivalent to a legally marketed predicate device (K020580) with only the addition of a hydroxyapatite (HA) coating to enhance tissue adherence. Therefore, the required information for acceptance criteria and study details cannot be extracted from the provided text.

Specifically, the document states:
"Clinical Testing: None provided"

Without clinical testing, there are no acceptance criteria based on patient outcomes, no device performance data from a clinical trial, and no details regarding sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies. The device's approval is based on its substantial equivalence to a predicate device and non-clinical mechanical testing and engineering analysis.

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