(85 days)
The 32 mm ceramic femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems. 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 joint involvement, for whom restoration of joint mobility leads to an expectation of greater mobility and an improvement in the quality of life.
Not Found
The provided text describes a 510(k) premarket notification for a 32 mm Zirconia Ceramic Femoral Head. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets such criteria.
The document primarily focuses on:
- The FDA's review and determination of substantial equivalence to legally marketed predicate devices.
- The product name and regulation details.
- The indications for use for the device when used with specific hip systems (Consensus® or UniSyn®).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details (sample size, provenance, expert qualifications, adjudication, MRMC study, standalone performance), or ground truth establishment based on the provided text.
§ 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.