(158 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina composite ceramic femoral head designed to be used as one component of a system of prostheses in hip arthroplasty. The femoral heads are available in a wide range of outer diameter sizes and offsets.
This document does not contain an AI device or any information about acceptance criteria and performances related to AI devices. The document is a 510(k) premarket notification for a medical device called "ARTICUL/EZE Ceramic Heads," which are ceramic femoral heads for hip arthroplasty. The content mainly discusses the substantial equivalence of this device to previously marketed predicate devices based on non-clinical performance testing.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.