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Synthes TomoFix™ Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.

The TomoFix™ Osteotomy System consists of five different titanium plates with locking and combination holes. There are two plates (left and right) for the lateral distal femur, 2 plates (left and right) for the lateral proximal tibia, and 1 plate for the medial proximal tibia.

This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text is a 510(k) premarket notification summary for the Synthes TomoFix™ Osteotomy System.

It primarily focuses on:

• Device Description: What the device is made of and its components.
• Intended Use: What the device is designed to treat.
• Classification: The regulatory class of the device.
• Predicate Device: Other similar devices that have already been cleared.
• Regulatory Correspondence: An FDA letter confirming substantial equivalence to predicate devices, allowing the device to be marketed.

This type of submission to the FDA (a 510(k)) generally demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or non-clinical study in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot extract the requested information, as it is not present in the provided text.

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