(148 days)
The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
The LIFE SPINE Subtalar implants are intended for single use only.
The LIFE SPINE Subtalar Implant System is a one piece titanium implant for treating hyperpronation of the foot. The system includes instruments (trial sizers, k-wires, and driver) to facilitate placement of the implant. Implants are manufactured from titanium alloy (Ti 6Al-4V ELI).
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Subtalar Implant System components with components from any other system or manufacturer. The Subtalar Implant System components should never be reused under any circumstances.
This document is a 510(k) premarket notification for a medical device called "The LIFE SPINE Subtalar Implant System". It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document primarily focuses on regulatory approval based on substantial equivalence, which often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from this document.
§ 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.