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Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies
5. Tumor resections
6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
7. Revision of previously failed total joint arthroplasty
8. Trauma

These devices are to be used with bone cement unless a proximal femur is indicated for use (USA)

When used with Biomet's Compress Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.

The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end of the femur including the knee articulating surface. The Proximal Femoral Bodies with a Compress® Female Taper are designed to replace the proximal end of the femur including the hip articulating surface. These components are intended for use with Biomet's Compress® Segmental Femoral and Orthopedic Salvage Systems. The new devices that are the subject of this 510(k) have a taper bore that is directly compatible with the taper of the Compress spindle eliminating the need for a taper adapter and allowing for smaller resection lengths.

This document is a 510(k) summary for a medical device (orthopedic implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states:

• "Non-Clinical Testing: None provided as a basis for substantial equivalence."
• "Clinical Testing: None provided as a basis for substantial equivalence."

Instead, this 510(k) relies on demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is considered as safe and effective as existing devices without requiring new clinical trials or performance studies against specific acceptance criteria.

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