(64 days)
The Orthofix Femoral Nailing System is indicated for the following: traumatic fractures; pathological fractures; refractures; non-unions; reconstructive surgery; and bone transport.
The Orthofix femoral nail is manufactured from surgical grade stainless steel. The nail is available in five diameters, 9, 10, 11, 12 and 13 mm and varying lengths. The nails have two proximal and two distal locking holes. The screws are also manufactured from surgical grade stainless steel. They have a self tapping thread and are available in varying lengths. End caps are provided which screw into the nail's proximal end, preventing tissue ingrowth and allowing for easier explantation. The end caps are also manufactured from surgical grade stainless steel.
The system includes various instruments and accessories used during the implantation and removal of the nail and locking screws. They include drill bit kits, hand and flexible reamers, an awl, trocars, guide wires, a bone depth gauge, a slap hammer impactor/extractor, an X-ray overlay, a metal ruler, a screw extractor, sterilization boxes, guides, wrenches and other tools.
The provided text is a 510(k) summary for the Orthofix® Femoral Nailing System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving performance against acceptance criteria in the context of a machine learning or AI device.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.
The document primarily states:
- Device Name: Orthofix® Femoral Nailing System
- Intended Use: Traumatic fractures; pathological fractures; refractures; non-unions; reconstructive surgery; and bone transport.
- Material: Surgical grade stainless steel.
- Predicate Devices: Howmedica Grosse & Kempf Locking Nail System (K860756) and Smith & Nephew Richards Femoral Interlocking Nail System.
- Substantial Equivalence: Claimed based on intended use, indicated use, material composition, size, and shape to the predicate devices and the manufacturer's own Tibial Nailing System (K961027).
There is no mention of acceptance criteria or a study proving device performance against such criteria in the context of an AI/ML device. The submission is purely for a physical implantable 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.