(156 days)
The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, subcapital (intra capsular), and base of neck fractures of the proximal femur.
The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and up to two distal locking bolts.
This 510(k) summary (K083648) describes a medical device, "The Gotfried PH (Physiological Hip) Nail," which is an intramedullary nail for hip fracture fixation. However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include information on software performance.
The document is a standard 510(k) summary for a Class II medical device (Intramedullary fixation rod). It primarily focuses on:
- Identification of the device and its submitter.
- Classification of the device and its predicate devices.
- Description of the device: An intramedullary nail with two proximal dynamic femoral neck screws and up to two distal locking bolts, made of stainless steel.
- Intended Use: Fractured bone stabilization, fixation, and management of specific types of proximal femur fractures (trochanteric, subtrochanteric, subcapital, and base of neck).
- Comparison to predicate devices: States that it is "substantially equivalent" in technology, construction, materials, and orthopedic design principles. It explicitly mentions its dimensions and tolerances are within the range of previously cleared devices.
Therefore, I cannot provide the requested table and information about acceptance criteria and study details because the provided text does not contain this information. This type of information (performance studies, acceptance criteria for software, sample sizes, ground truth) is typically found in the more detailed sections of a 510(k) submission, not usually in the publicly available 510(k) summary document itself, especially for a hardware device like an intramedullary nail. The substantial equivalence argument for this device relies on its similarity to existing, legally marketed predicate devices, rather than on new performance studies with specific acceptance criteria that would be relevant for software or AI.
§ 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.