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The Encore CLP Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post - traumatic arthritis, collagen disorders, avascular necrosis, Protrusio Acetabuli, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip displasia, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Encore CLP Offset Hip Stem is intended for Cementless Applications

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Encore CLP™ Offset Total Hip System," which indicates the device has been found substantially equivalent to legally marketed predicate devices.

The letter discusses:

• The device name and regulation numbers.
• The substantial equivalence determination.
• General controls and additional regulations applicable to the device.
• Instructions for marketing the device and obtaining further advice.
• The "Indications for Use" for the Encore CLP Offset Total Hip System.

It does not include any performance data, study designs, sample sizes for testing or training, expert qualifications, or details about how ground truth was established, which are all typically found in study reports describing acceptance criteria validation.

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