(27 days)
The S2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty .
- Fractures distal to a hip joint .
- Nonunions and malunions .
The subject S2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
This document describes a Special 510(k) Premarket Notification for a line extension to the S2 Femoral Nail System. It does not contain information about software or AI/ML device performance, acceptance criteria, or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document primarily focuses on the substantial equivalence of new components (larger diameters of the nail, Condyle Screws, Condyle Nut, and an additional End Cap) to a predicate device, based on material identity and comparable mechanical properties demonstrated through mechanical testing.
The questions you've asked are typically relevant for AI/ML-driven medical devices that involve performance metrics like sensitivity, specificity, or accuracy, and require studies with expert-derived ground truth. This document describes a physical medical implant, not an AI/ML 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.