Search Results

The indications for use of the AVL Hinge Knee System 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 for cemented use only.

The AVL Hinge Knee System is composed of a modular femoral component that is joined to a modular tibial component by means of a yoke and an axle. A polyethylene bearing is located between the femoral and tibial components.

This document does not contain information about acceptance criteria or a study proving device performance.

The provided text is a 510(k) summary for the Biomet AVL Hinge Knee System. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Specifically, the "Clinical and Non-Clinical Testing" section explicitly states: "None provided". This means no studies demonstrating device performance were included in this 510(k) submission. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Ask a specific question about this device

Ask a specific question about this device