(47 days)
The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
The provided text does not contain information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria in the context of a performance study like an AI/ML device.
This document describes a 510(k) premarket notification for a medical device called the OrthoPediatrics PediFlex™ Flexible Nail System, which is an intramedullary elastic nail. The focus of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria for a new clinical efficacy or diagnostic accuracy claim.
The "Basis for Substantial Equivalence" section explicitly states: "OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications."
Therefore, I cannot provide the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert qualifications, or details about MRMC studies or standalone algorithm performance. These types of studies are typically associated with devices that have a new clinical function or AI/ML components requiring validation against specific performance metrics, which is not the case for this 510(k) submission.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.