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The M³a™ Magnum™ System is indicated for use in patients requiring total hip replacement due to the following:

• Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures and traumatic arthritis.
• Rheumatoid arthritis .
• · Correction of functional deformity
• · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• · Revision of previously failed total hip arthroplasty

The M a ™ Maqnum™ System consists of a CoCrMo monolithic acetabular cup, which articulates with a CoCrMo modular head. The smaller femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from –6mm to +12mm. The larger femoral heads, sizes 42mm to 60mm, are a modular design with neck length variations ranging from -6mm to +9mm, achieved through the use of a titanium adapter assembled with the modular head component at the time of surgery. The femoral heads may be used in conjunction with any of Biomet's commercially available Type I taper femoral component.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for the M2a™ Magnum™ System, detailing its classification, predicate devices, and indications for use. It explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, or study details.

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