(55 days)
The system is indicated for fixation of the following conditions where the area requiring fixation is distal to the tibial tuberosity and at least 55 mm proximal to the distal articular surface: acute traumatic fractures; pathological fractures; delayed or non-unions; stabilization after corrective osteotomy; and bone transport.
The Orthofix Tibial Nailing System includes a series of tibial nails of varying diameters and lengths, locking screws and end caps, as well as the instruments and accessories used in their implantation and removal.
The system will include tibial nails which range from 8 to 14 mm in diameter and from 240 to 440 mm in length. These nails are manufactured from surgical grade stainless steel (AISI 316L) and include both solid and cannulated constructions. Nails are included for reamed and unreamed use. The nails have a proximal bend and may contain proximal, intermediate and distal locking holes.
This document (K961027) is a 510(k) summary for a medical device called the Orthofix® Tibial Nailing System, which is an intramedullary fixation rod. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.
Based on the provided text, the Orthofix® Tibial Nailing System is a physical medical device (intramedullary nail system for bone fixation), not an AI/ML device or software. Therefore, the questions regarding acceptance criteria, study details (sample size, ground truth, expert involvement, MRMC, standalone performance), and training set information are not applicable. These types of questions are relevant for evaluating the performance and validation of AI/ML or diagnostic imaging devices, not for a physical orthopedic implant system like this.
The 510(k) submission process for such a device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical performance studies with acceptance criteria in the format typically seen for AI/ML or diagnostic devices.
The text does specify that the device is an "Intramedullary Fixation Rod" (21 CFR 888.3020) and the submission's purpose is to notify FDA of Orthofix's intention to commercially distribute its previously cleared Unreamed Tibial Nail System with additional tibial nails and instrumentation, and that it remains substantially equivalent to itself and other legally marketed predicate devices.
§ 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.