(90 days)
Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:
Link Acetabular Mesh Cup and Sheet
This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Acetabular Revision Mesh and Cup" (Link America, Inc. Acetabular Mesh Cup and Sheet). It confirms substantial equivalence and permits marketing of the device.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document focusing on substantial equivalence to previously marketed devices. Therefore, I cannot extract the requested details from the given input.
§ 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.