(255 days)
The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases:
- . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.
The Medtronic Total Hip Arthroplasty System is a total hip system for the restoration of alignment, stability range of motion, and alleviation of pain, by replacing the articulating surfaces of the hip joint. The system includes femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
New acetabular components including highly crosslinked UHMWPE acetabular liners and porous coated cups are the subject of this 510(k).
I am sorry, but the provided text does not contain information about an AI/ML-based medical device. The document is an FDA 510(k) clearance letter for the Medtronic Total Hip Arthroplasty System, a physical medical device (hip prosthesis).
Therefore, I cannot provide details on acceptance criteria, study methodologies, or performance related to AI/ML models as these elements are not present in the document. The document explicitly states: "Clinical Testing was not required for these products." and focuses on non-clinical (bench) testing for the hip implant's materials and wear characteristics.
§ 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.