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The Medtronic Sofamor Danek Block Cement Restrictor (CR) - Titanium is intended for use as a cement restrictor in orthopedic surgeries in the femur and tibia in hip and knee replacement.

The Block CR-Titanium is NOT intended for any spinal indications.

The BLOCK CR - TITANIUM is a tapered block that is titanium. The device is intended to be used in conjunction with standard PMMA cement.

The BLOCK CR - TITANIUM implants are manufactured from titanium alloy as described by ASTM F136 or ISO 5832-3.

The purpose of this submission is to obtain clearance for the alternative design. All other aspects of the device including material, indications for use, and fundamental scientific technology are the same as the previous cleared TITANIUM CEMENT RESTRICTOR.

This 510(k) summary for the BLOCK CR - TITANIUM device does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria and Reported Performance Table: The document describes the device, its intended use, and its substantial equivalence to a predicate device. It explicitly states, "A Design Review for the device was provided in this submission." However, the 510(k) summary itself does not provide an acceptance criteria table or the results of any specific performance testing. In a 510(k), manufacturers often rely on substantial equivalence to a predicate device rather than conducting new clinical studies with defined acceptance criteria for performance.

• No Study Details:

  • Sample size and data provenance: Not mentioned.
  • Number and qualifications of experts: Not mentioned.
  • Adjudication method: Not mentioned.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a physical implant, not an AI or imaging diagnostic tool, so an MRMC study would generally not be applicable.
  • Standalone algorithm performance: Not applicable as it's not an algorithm.
  • Type of ground truth: Not mentioned, and likely not applicable in the context of this device's regulatory pathway.
  • Training set sample size and ground truth establishment: Not applicable as it's not a machine learning model.

What the document does indicate regarding "proof":

The document relies on the concept of Substantial Equivalence. The key statement is:

"The BLOCK CR - TITANIUM was demonstrated to be substantially equivalent to previously cleared devices such as TITANIUM CEMENT RESTRICTOR (K003718). A Design Review for the device was provided in this submission."

This means that instead of conducting new performance studies against predefined acceptance criteria, the manufacturer demonstrated that the new device is as safe and effective as a legally marketed predicate device (K003718) because:

• It has the same intended use.
• It has the same technological characteristics (made from titanium alloy, used with PMMA cement).
• Any differences in technological characteristics (alternative "tapered block" design) do not raise new questions of safety or effectiveness.

The "Design Review" mentioned would have likely included engineering analyses, material testing (referencing ASTM F136 or ISO 5832-3), and potentially bench testing to ensure the device performs as intended and is comparable to the predicate. However, specific results of these tests and the acceptance criteria used are not included in this summary.

In summary, based only on the provided text, it's not possible to provide the requested information because the 510(k) summary relies on substantial equivalence rather than reporting on a study designed to meet specific acceptance criteria for device performance as would be detailed for a new in-vitro diagnostic or AI device.

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