Search Results

The cobalt-chrome unipolar 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:

• A) Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or degenerative arthritis, and avascular necrosis with a non-acute fracture of the femoral neck.
• B) Osteoarthrosis involving femoral and acetabular articular surfaces.
• C) Avascular osteonecrosis and/or non-union of acute femoral neck fractures.
• D) Fracture or dislocation of the hip.
• E) Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

With UniSyn® System:

• A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
• C) Proximal femoral fractures.
• D) Avascular necrosis of the femoral head.
• E) Non-union of proximal femoral neck fractures.
• F) 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.
• G) 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

The cobalt-chrome unipolar femoral head is design for use with the Consensus® or UniSyn ® Hip Systems, and is not intended for substitution with components of other systems.

This is a 510(k) premarket notification for a medical device (Consensus Unipolar Head, CoCr), which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving the device meets those criteria.

Therefore, the provided document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-driven medical device.

The information in the document pertains to:

• The FDA's determination of substantial equivalence for a hip joint femoral prosthesis.
• The regulation number and name for the device.
• The product code and regulatory class.
• The indications for use for the device when used with the Consensus® Hip System and the UniSyn® Hip System.

Ask a specific question about this device