(126 days)
Total hip and knee joint replacement in cases of:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
- Correction of varus, valgus or post traumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Ligament deficiencies
- Tumor resections
- Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
- Revision of previously failed total joint replacement
- Trauma
The IM Total Femur is, in simplest terms, an intramedullary (IM) rod which connects a proximal hip replacement component to a knee femoral replacement component.
The IM rods are slightly bowed to mimic the natural femur and find appropriate alignment. Both ends of the rod have a male taper for connection to the hip proximal femur and a knee femoral component. Following impaction, a locking screw further secures the parts. Two types of IM rods are available based on the tapers of the distal knee component selected by the surgeon. IM total femur rods with an "Impact" taper at one end and an "OSS" taper at the other come in 1cm increments for replacements of 35cm to 45cm. The second type of rod have an "Impact" taper at both ends and come in 3cm increments for replacement from 34 to 46cm.
Femoral knee components are available with both "OSS" and "Impact" taper bores. The femoral knee components articulate with previously cleared tibial bearings, base-plates and femoral components. The device is compatible with any of Biomet's proximal modular hip components.
The provided text describes the 510(k) summary for the Biomet IM Total Femur device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.
The document is a regulatory submission for a medical device (an intramedullary rod connecting hip and knee replacement components), and its primary purpose is to demonstrate substantial equivalence to previously marketed devices. It focuses on device description, intended use, and a summary of technologies.
The "Non-Clinical Testing" section
{1} states: "Mechanical testing has shown the tapers capable of withstanding expected loading conditions." This is a very generalized statement and does not provide specific acceptance criteria or detailed study results.
The "Clinical Testing" section
{1} explicitly states: "None provided."
Therefore, based on the input provided, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them because this information is not present in the given text.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.