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The indications for Lateralized Integral Hip Component are the same as with any other hip replacement, namely:

• a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• b.) rheumatoid arthritis
• c.) correction of functional deformity
• d.) revision procedures where other treatments or devices have failed
• e.) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
  The Lateralized Integral Hip Component is intended for press-fit application and single use implantation.

The Lateralized Integral Hip Component is an evolution of Biomet's successful BiMetric family. The lateralizion is achieved by moving the trunion/taper 6-mm medially, thereby moving the axis of rotation 6-mm lateral. The horizontal offset of the femoral neck addresses the need to increase joint stability by tensioning the soft tissue. The same design is employed on the Lateralized Taperloc, another of Biomet's stems.
The proximal geomerry of the Integral femoral component is designed to promote distal filling of the metaphysis. A porous coated duckbill collar is incorporated to provide stability and stress transfer. This helps to provide rotational stability and facilitates potential ingrowth and load transfer.
The proximal to distal taper of the femoral stem parallels the shape of the femur canal, allowing a gradual decrease in the stresses transferred to the bone from proximal to distal.
The 3-degree compound proximal to distal taper helps the device to achieve exceptional fit. The stems are proportionally sized and shaped 9- mm to 19-mm diameters in 1-mm increments, and from 125 to 175 mm in length in 5 increments. The straight stem design of the primary component eliminates the need for a left or right configurations.
The femoral component utilizes a modular head, which is taper-fit on to the stem at the time of surgery. The modular head is manufactured from wrought titanium or cobaltchromium-molybdenum conforming to ASTM F-620 and F-1537 respectively.

This document is a 510(k) premarket notification for a medical device and therefore does not contain information about acceptance criteria or a study proving the device meets said criteria.

The provided text details:

• Sponsor and Contact Information
• Device Name and Classification
• Intended Use
• Device Description
• Potential Risks
• Substantial Equivalence: It compares the "Lateralized Integral femoral component" to existing predicate devices, namely the "Biomet Integral Primary Porous (K921225)" and "Biomet Lateralized Taperloc Hip System (K921301)." The FDA determined that the device is substantially equivalent to these devices.

To answer your request, a study demonstrating device performance against specific acceptance criteria would typically be found in a more detailed technical report, clinical study, or design validation documentation, which is not part of this 510(k) summary. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel device.

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