(28 days)
The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail.
Intended Use for the Long Length Dyax Nail
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, malunion, pathological fractures, and impending pathological fractures.
Intended Use for the Trochanteric Dyax Nail
The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
This Special 510(k) submission is intended to address a design modification of the Dyax Lag Screw to create the subject device which is referred to as the Gamma 3 Lag Screw. The design modification involves changes to the thread diameter; thread radius and cutting flute design. The subject device is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. The design modification involves changes to the thread diameter; thread radius and cutting flute design
The provided text is a 510(k) Premarket Notification for a design modification of a medical device (Dyax Lag Screw to Gamma 3 Lag Screw). It describes the device, its intended use, and its substantial equivalence to a previously cleared product. However, this document does not contain any information about acceptance criteria, device performance studies, or clinical trial details.
The 510(k) summary explicitly states: "This Special 510(k) submission is intended to address a design modification of the Dyax Lag Screw to create the subject device which is referred to as the Gamma 3 Lag Screw. The design modification involves changes to the thread diameter; thread radius and cutting flute design. ... There is no change in intended use for the modified device when compared to the previously cleared product. The subject Gamma 3 Lag Screws are substantially equivalent to the existing design of Dyax Nail Lag Screw that were determined substantially equivalent via the 510(k) process."
This indicates that the FDA cleared the device based on its substantial equivalence to a predicate device, meaning it's similar enough that new clinical performance data was not required for this particular submission. Therefore, I cannot extract the requested information from the provided text.
To answer your questions, I would need a document that describes:
- Specific performance metrics (e.g., strength, durability, fit).
- Testing methodologies used to evaluate these metrics.
- Results of such tests compared against predefined acceptance criteria.
- Details of any studies (biomechanical, cadaveric, or clinical) that were conducted for the original device or to support the "substantial equivalence" of the modified device.
§ 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.