(1030 days)
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.
This document describes a medical device, the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail, and its sterilization validation, not the performance of an AI or diagnostic device that would typically have acceptance criteria related to accuracy or other performance metrics.
Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC study, standalone performance, training set details) are not applicable to this document.
This document focuses on:
- Device Description: A tibial nail for stabilizing fractures.
- Material: Titanium-6Aluminum-7Niobium.
- Sterilization Method: Gamma radiation.
- Sterilization Validation: Biological Indicator - Overkill Method, following AAMI guidelines, ensuring a sterility assurance level in excess of 10^-6.
- Packaging: Double sterility barrier using PETG plastic trays and Tyvek lids.
- Radiation Dose: 2.5 - 3.2 MegaRads (validation minimum dose range per AAMI is 1.8 - 2.6 MegaRads).
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.