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The indications for use of the Cemented Calcar Hip System in total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The Cemented Calcar Hip Stem is intended for use with bone cement.

The Cemented Calcar Hip Stem is fabricated from wrought titaniumaluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136. The Cemented Calcar Hip Stem is available in sizes 12-16, which have diameters from 10-14mm and lengths of 18-20cm. The proximal body is polished and designed with filleted holes for cerclage cables. The distal and lateral portions of the stem are gritblasted. The Cemented Calcar Hip Stem is designed with a 1320 neck angle and a Morse taper to accept the femoral head. The distal portion of the stem tapers to accept a distal centralizer.

The Cemented Calcar Hip Stem is to be implanted either with or without a collar. The modular collar is available in a +15 and +30mm height for each size stem. The collar is attached to the stem using an attachment screw. The modular collars are fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The attachment screw is used to attach the collar to the Cemented Calcar hip stem. The attachment screw is fabricated from wrought titanium-aluminum-vanadium alloy (Ti-6Al-4V) conforming to ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device (Cemented Calcar Hip System) and the FDA's substantial equivalence determination. It does not include information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document clarifies the device's description, intended use, and comparison to predicate devices based on materials, design, and indications, but does not present a performance study with acceptance criteria.

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