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This device is intended to be used for :

• noninflammatory 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 non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The implant will consist of a solid, rectangularly cross-sectioned wrought titanium 6Al- 4 V (ASTM 1472) stem with a tapered proximal end and is intended to seat a conventional modular spherical head. The device is intended to articulate with a conventional acetabular implant of the surgeon's choice. The distal portion will be a smooth taper anterior-posteriorly and will have step-cut sides medial-laterally. The proximal stem will be porous coated with commercially pure titanium plasma spray on all surfaces excluding the articular interface trunnion.

The provided text is a 510(k) summary for a medical device (Quatroloc Plasma Sprayed Femoral Component) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against detailed acceptance criteria through a specific study as would be seen in a clinical trial or performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided document. The document primarily describes the device, its intended use, manufacturer information, and the FDA's decision regarding its clearance based on substantial equivalence.

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