(90 days)
The Theken Small Cement Restrictor is intended for use as a cement restrictor in orthopaedic surgeries such as those involving the tibial plateau in total knee replacement. The Theken Small Cement Restrictor is NOT intended for any spinal indications.
The Theken Small Cement Restrictor is a hollow, titanium, and rounded rectangular frame with fenestrations on all sides and toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a 510(k) summary for a medical device (Theken Small Cement Restrictor) that primarily focuses on demonstrating substantial equivalence to a predicate device.
The "Performance Data" section of the 510(k) summary states: "Non-clinical: Static evaluation was performed and the strength of the device was characterized." This indicates that some testing was performed to characterize the device's strength, but it does not provide specific acceptance criteria, detailed study design, or results in a format that would allow for the completion of the requested table and information.
Therefore, I cannot complete the requested information based on the provided text.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.