(83 days)
The Zimmer Anatomic II Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
The Zimmer Anatomic II Hip Prosthesis is an anatomically shaped femoral stem for use in total hip arthroplasty. It is manufactured from Tivanium® Ti-6Al-4V Alloy and utilizes a modular junction between the head and neck. Biological fixation is achieved with the use of a Tivanium Ti-6A1-4V plasma spray coating. The modular connection of the femoral stem is a Morse-type 12/14 taper designed to mate with the corresponding femoral head component. Zimaloy® Co-Cr-Mo Alloy femoral heads are available for use with the femoral stem or, where available, Alumina Ceramic Femoral Heads. The modified Zimmer Anatomic Stems have been developed to increase surgeons' options so that they may meet the large variety of anatomical needs of their patients.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Zimmer Anatomic II Hip Prosthesis. It describes the device, its intended use, and its comparison to a predicate device. The information does not contain any acceptance criteria, performance data, or study details as requested in the prompt.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
The document explicitly states:
- "Non-Clinical Performance and Conclusions: Non-clinical performance testing demonstrated that the modified device is equivalent to the predicate."
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This indicates that the submission relied on demonstrating substantial equivalence to a legally marketed predicate device (Zimmer Anatomic Hip Prosthesis, K922071) through non-clinical performance testing, rather than presenting new clinical or non-clinical studies with specific acceptance criteria.
§ 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.