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The device is Intended for use in total hij› arthroplasty. The device is intended for uncemented, press-fit use only.

• 1. Notably impaired hip joint due to usteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• 2. Previously failed surgery.
• 3. Proximal femoral neck fractures or dislocation.
• 4. Idiopathic avascular necrosis of the femoral head.
• 5. Non-union of proximal femoral ne :k fractures.
• 6. Treatment of fractures that are un nanageable using other forms of therapy.
• 7. Benign or malignant bone tumors congenital dysplasia or other structural abnormalities where sufficient bo re stock exists to properly seat the prosthesis.

Encompass™ Plasma Sprayed, Press-fit Hip System: Encompass™ Hip Stem, Tri-plus™ Acetabular Shell, Tri-plus™ DCM Liner

The provided document is a 510(k) clearance letter from the FDA for the Encompass™ Plasma Sprayed, Press-fit Hip System. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria as typically found in a clinical or performance study report. It is a regulatory clearance, not a performance evaluation.

Therefore, I cannot extract the requested information. The document primarily focuses on regulatory classification, indications for use, and confirmation of substantial equivalence to a predicate device.

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