(89 days)
The Ti coated porous acetabular shell is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. The device is intended primarily for uncemented, press-fit applications. The indications for use are:
With Consensus® System:
- Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
- Osteoarthrosis involving femoral and acetabular articular surfaces.
- Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
- Fracture or dislocation of the hip.
- Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.
With UniSyn ® System:
- Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- Proximal femoral fractures.
- Avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
- Indications for the use of the UniSyn Hip System must be carefully considered with respect to the patient's entire evaluation and alternative procedures. Patient selection is dependent on age, general health, available bone stock and quality, and any prior surgery or anticipated future surgery. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity. Total joint replacement in younger patients should be considered only when explicit indications outweigh the associated risks of the surgery and modified demands regarding activity and joint loading are assured. This includes all patients who may or may not have multiple ioint involvement, for whom restoration of ioint mobility leads to an expectation of greater mobility and an improvement in the quality of life.
Acetabular Shell, Porous Ti TI Coating
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria.
The document is a letter from the FDA regarding a 510(k) premarket notification for an "Acetabular Shell, Porous Ti TI Coating." It states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses. However, it does not include any performance data, clinical study results, or specific acceptance criteria.
Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies.
§ 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.