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K Number
K210994
Device Name
Arthrex Beveled FT Screws
Manufacturer
Arthrex Inc.
Date Cleared
2021-06-01

(60 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K201132,K162353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Arthrex Beveled FT Screws are indicated for fixation of bone reconstruction. Examples include:

  • . Mono or Bi-Cortical osteotomies in the foot or hand
  • . Distal or Proximal metatarsal or metacarpal osteotomies
  • . Weil osteotomy
  • . Fusion of the first metatarsophalangeal joint and interphalangeal joint
  • . Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
  • Akin type osteotomy
  • Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus .
  • . Calcaneus/cuboid arthrodesis
  • Talar/navicular arthrodesis
Device Description

The Arthrex Beveled FT Screws are fully threaded, cannulated screws with self-tapping, tapering head. The screws will be offered in three diameters: 3.5 mm, 4.0 mm and 4.5 mm, and will range in lengths from 12 mm to 60 mm. The screws are manufactured from Titanium Alloy, conforming to ASTM Standards F1472. The screws are sold sterile and non-sterile and are single use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Arthrex Beveled FT Screws. It's a regulatory clearance document, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria and study data for an AI/ML device.

The "Performance Data" section describes mechanical and biological testing of the bone screws, confirming their physical properties, MRI compatibility, and biocompatibility, not performance of a software algorithm.

To answer your request, I would need a document describing the regulatory clearance for an AI/ML medical device.

§ 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.