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The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate. For Cemented Use Only

The Comprehensive Humeral Fracture Positioning Sleeve is composed of Polymethyimethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System (K023063). The device is a sleeve that fits over the distal tapered stem of the Comprehensive Fracture system and stops at a point below the fins of the stem.

The provided text is a 510(k) summary for the Biomet Comprehensive Humeral Fracture Positioning Sleeve. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them, as no such study or criteria are detailed in the provided documents.

The document indicates that an "engineering justification was utilized to determine that no additional mechanical testing was required." This suggests that mechanical testing results might exist supporting the device's equivalence, but these are not disclosed with specific acceptance criteria or performance data in this summary.

In summary, based on the provided text, the device's clearance was based on substantial equivalence to predicate devices and an engineering justification, not on a clinical study demonstrating performance against specific acceptance criteria.

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