(28 days)
The S2 Tibial Nail System is a fracture fixation device comprised of tibial 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.
The S2 Tibial 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 compression locked.
The S2 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 subject S2 Tibial Nail System is a fracture fixation device comprised of tibial 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 Special 510(k) submission is intended to address a line extension to the predicate S2 Tibial Nail System. The line extension involves offering larger diameters of the nail. In addition. Condyle Screws, a Condyle Nut and an additional End Cap will be added to the system. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. There is no change in intended use for the modified device when compared to the previously cleared device.
The provided text describes a Special 510(k) submission for a line extension to the S2 Tibial Nail System. This document is for a medical device (intramedullary nail) and its purpose is to extend the product line by offering larger diameters and adding new components.
Crucially, the document does not contain details about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the specific information requested in your prompt regarding artificial intelligence (AI) device evaluation.
The text focuses on:
- Submission Information: Sponsor, contact, date, device identification (proprietary name, common name, classification).
- Device Description: The line extension involves larger diameters and additional components (Condyle Screws, Condyle Nut, End Cap).
- Intended Use: Fracture fixation device for tibial nails and related components, providing strong and stable internal fracture fixation.
- Technological Comparison: Stating that the material is identical to the predicate and that FEA analysis and mechanical testing demonstrate comparable mechanical properties. This is the closest the document comes to mentioning any form of "study" or "performance."
- FDA Communication: A letter from the FDA confirming substantial equivalence to a predicate device.
- Indications For Use: Specific types of tibial fractures and conditions for which the device is indicated.
Since the document is about a mechanical orthopedic implant and not an AI-powered device, it does not include the type of information you've asked for within the context of AI device evaluation (e.g., test set, ground truth, MRMC study, standalone performance).
Therefore, I cannot extract the requested information (points 1-9) from the provided text.
§ 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.