(192 days)
The Patient Specific Acetabular Reconstruction Prosthesis is inlended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application.
The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip and diastrophic variant.
The Patient Specific Acetabular Reconstruction Prosthesis is an acetabular shell designed to match the natural geometry of an individual patient. Because each Patient Specific Acetabular Reconstruction Prosthesis component is designed to match a particular patient, taking into account his/her natural anatomy and bone stock, a specific device description is not possible.
The provided text describes a 510(k) summary for a "Patient Specific Acetabular Reconstruction Prosthesis." This document primarily focuses on the device description, intended use, indications, and substantial equivalence to existing devices.
Crucially, the document DOES NOT contain information regarding acceptance criteria, device performance studies, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer questions 2 through 9 based on the input text. The 510(k) summary is a regulatory submission for premarket notification, aiming to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically does not include detailed performance study results in the same way a clinical trial report or a scientific publication would.
§ 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.