LogoFDA 510(k) Search
K Number
K053543
Device Name
ARTHREX ARTHOERESIS IMPLANT
Manufacturer
ARTHREX, INC.
Date Cleared
2006-04-03

(104 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K960692,K001231,K042030,K031155
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Arthrex Subtalar (Arthoeresis) Implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar joint. It is intended to block forward, downward, and medial displacement of the talus thereby limiting excessive eversion of the hindfoot

Examples include:

  • Symptomatic acquired flat foot treatment in children and adolescents .
  • Symptomatic congenital flexible flat foot .
  • Tarsal coalitions when associated with a flatfoot deformity .
  • Posterior tibial tendon dysfunction with supple feet .
  • Paralytic flat foot .
Device Description

The Arthrex Arthroeresis Family is currently comprised of titanium allov implants according to ASTM F-136. They are offered in several different sizes. They are offered sterile.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. This document is a 510(k) summary for the Arthrex Arthroeresis Family, which outlines the device description, indications for use, and a statement of substantial equivalence to predicate devices. It discusses regulatory classification and general controls but does not include any performance data, study designs, or details regarding acceptance criteria for device performance.

Therefore, I cannot provide the requested information as it is not present in the given text.

§ 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.