(64 days)
The Trabecular Metal Acetabular Augment System is intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Trabecular Metal Acetabular Augments provides an alternative to structural allograft for augmenting moderate to large-sized segmental acetabular defects encountered in acetabular reconstruction. The Trabecular Metal Acetabular Augments possesses a truncated hemispherical geometry. The device is available in OD sizes 50 to 74 mm in 4 mm increments, and each size is offered in thicknesses from 5mm to 30mm in 5mm increments, aside from the 74mm implant which is available only in thicknesses of 10mm, 20mm and 30mm.
The provided text is a 510(k) summary for the Trabecular Metal Acetabular Augment System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.
This document is a regulatory filing asserting substantial equivalence, which typically relies on comparisons to existing devices and performance data that may have been generated for those predicate devices, or through design verification and validation activities (e.g., mechanical testing, biocompatibility testing) that are not detailed in this summary.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, and expert review based on the provided input. The document focuses on the regulatory submission process and the determination of substantial equivalence, not the detailed technical performance data or clinical study results.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.