(90 days)
The T2 Arthrodesis Nail is indicated for long bone internal fixation, which may include the following:
The subject device is indicated for long bone fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Ipsilateral femur fractures .
- Failed external fixation, nonunions and malunions .
- Periarticular fractures where repair is not possible .
- Aseptic failed total knee arthroplasty .
- Knee arthrodesis .
The T2 Arthrodesis Nails have a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with distal rounded end. The T2 Arthrodesis is available in lengths from 540 mm to 780 mm increments, and in diameters from 10 mm to 15 mm.
This 510(k) summary describes a medical device, the T2 Arthrodesis Nail System, which is an intramedullary nail for internal fixation of long bones. However, the provided document does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies of AI.
The document is a 510(k) premarket notification summary and a subsequent FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than providing detailed performance study data against specific acceptance criteria.
Therefore, I cannot provide the requested table and study details. The information necessary to answer your questions is simply not present in the provided text.
The document only states the following:
- Proprietary Name: T2 Arthrodesis Nail System
- Common Name: Intramedullary Nail
- Intended Use: Internal fixation system comprised of intramedullary nails and related locking screws, compression screws, and end caps. Intended to provide strong and stable internal fixation with minimal soft tissue irritation, aiding healing.
- Indications for Use: Long bone internal fixation, including open/closed femoral fractures, pseudoarthrosis, correction osteotomy, pathologic fractures, ipsilateral femur fractures, failed external fixation, nonunions, malunions, periarticular fractures (where repair isn't possible), aseptic failed total knee arthroplasty, and knee arthrodesis.
- Substantial Equivalence: Claimed to be substantially equivalent to predicate devices in design and function. Both subject and predicate systems offer nails in varying lengths and combinations of locking screws, compression screws, and end caps.
To answer your questions, I would need a different type of document, such as a full clinical study report, a bench test report, or a detailed performance validation report, which are typically part of a more extensive submission but not always included in the public 510(k) summary.
§ 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.