(79 days)
The Titan Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The Titan Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Open and closed tibial fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Nonunion and malunion
The Titan Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and an end cap are manufactured from titanium alloy and are used with the nails. The Titan Tibial Locking Nail is available in three versions, each differing from the other only in diameter, length and number and orientation of screw holes.
The design and function of the Titan Tibial Locking Nail is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer tibial nails in varying lengths, and offer a combination of locking screws, compression screws and end caps, the combination of which varies depending on which system is used.
The provided text is a 510(k) summary for the Titan Tibial Nail and a letter from the FDA. It does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, not on proving performance against specific acceptance criteria through a detailed study.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The text does not describe an acceptance criteria table, device performance metrics, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and test sets.
§ 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.