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510(k) Data Aggregation
K Number
K040122Device Name
MAYO CLINIC BC-10 3.0T
Manufacturer
Mayo Clinic
Date Cleared
2004-04-14
(85 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Mayo Clinic
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.
Device Description
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
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K Number
K943230Device Name
MAYO HIP PROSTHESIS
Manufacturer
Mayo Clinic
Date Cleared
1997-01-14
(923 days)
Product Code
LPH
Regulation Number
888.3358Why did this record match?
Applicant Name (Manufacturer) :
Mayo Clinic
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of surgery. This hip is indicated for noncemented use in skeletally mature individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Device Description
The MAYO Hip Prosthesis is a short-stemmed, press-fit modular femoral component developed by Bernard F. Morrey, M.D., of the Mayo Clinic and is intended to be implanted into the human femur to replace a hip joint. The MAYO Hip incorporates several technological features of the Zimmer Anatomic Hip Prosthesis (and other predicate devices) such as the Morse-type tapered neck and fiber metal pads for bone ingrowth, and is made from the same materials (titanium alloy and commercially pure titanium) as the predicate devices. The femoral stem is collarless, has a dual taper (double wedge) body, and has a short distal stem (tail). The femoral stem is available in four sizes each of which can be utilized in the left or right hip.
The modular femoral stem is designed to mate with a femoral head through a Morse-type taper. The femoral head in turn articulates upon the UHMWPE liner of an acetabular component. The MAYO Hip Prosthesis meets the criteria of the generic device described in 21 CFR 888.3358.
The MAYO Hip supports a conservative approach to total hip arthroplasty by allowing for minimal femoral neck resection, minimal bone preparation, minimal stress shielding, absence of intramedullary fixation, reduction in blood loss, and potential for ease of revision.
The short distal portion of the stem is used to assist in proper placement of the stem and provides for rotary fixation. Immediate fixation is achieved through three-point (anteroposterior and lateral planes) fixation in the metaphyseal bone of the proximal femur. The stem does not rely upon intramedullary fixation, therefore the source of thigh pain is eliminated. Surgery time is reduced because the femoral medullary canal is not reamed or violated. This results in statistically significant less blood loss than that of a conventional, uncemented primary total hip arthroplasty. Additionally, reduction in the amount of metal (due to the short distal stem and double wedge shape) results in less exposure of a foreign body to the intramedullary canal. The conservative femoral neck resection, which preserves bone stock, will facilitate subsequent procedures should a revision of the hip be required.
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