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The Reach Femoral Component is indicated for use in:

• non-inflammatory degenerative joint disease a.
• oseoarthritis b.
• avascular necrosis c.
• d. rheumatoid arthritis
• revisions procedures where other devices or treatments have failed e.
• f. correction of functional deformities
• treatment of non-unions, femoral neck and trochanteric fractures of the g. proximal femur with head involvement.

The Reach Femoral Stems are intended for press-fit application and for single use implants.

The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with any Biomet's acetabular component.

The Reach stem geometry is designed for proximal, as well, distal stability and gradual offloading into the bone along the canal. The proximal 100-mm of each stem incorporates a bi-planer taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability.

The stem has a duckbill porous coated collar, which is incorporated to provide component stability and stress transfer. The underside of the collar is porous coated to help ensure collar-clacar contact and stress distribution. This helps to provide rotational stability and load transfer.

Distally, the stem is cylindrical with an anterior bow for left and right specific applications. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. The cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies.

The Reach femoral stems will be fully coated to provide maximum proximal and distal fixation through potential bony ingrowth. This circumferetial closed-pore porous coating potentially seals the femur from debris migration. Porous coating in the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long-term success. The distal tip of the stem is a polished finish, to prevent distal off loading and fixation of the tip (otherwise known as the "pedestal effect").

The provided document is a 510(k) premarket notification for a medical device called the "Reach Femoral Hip Component." It describes the device, its intended use, potential risks, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics. The FDA's letter explicitly states that the device is determined to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the information provided. The document simply doesn't contain that type of data.

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