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K Number
K153333
Device Name
Epic Extremity Cannulated Screw System
Manufacturer
Epic Extremity, LLC
Date Cleared
2016-01-19

(61 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K082320,K080101
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Epic Extremity Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the device.

Screws are intended for single use only.

Device Description

The Epic Extremity Cannulated Screw System will consist of multiple diameter headed and headless cannulated screws of various lengths and instruments to assist in implanting the system.

AI/ML Overview

This document is a 510(k) summary for the Epic Extremity Cannulated Screw System, which is a medical device. As such, it does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML model's performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

  1. Intended use and indications for use, which are similar to the predicate devices.
  2. Technological characteristics, specifically that the device is manufactured from the same material (Ti-6Al-4V per ASTM F-136) and has a similar range of sizes as the predicate devices.
  3. Non-clinical performance data, referencing ASTM F-543.
  4. No clinical performance data was required for this 510(k) submission.

Therefore, I cannot provide the requested information. The document explicitly states: "No clinical testing was required," and "No clinical performance data was done."

§ 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.