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K Number
K050634
Device Name
MODIFICATION TO: ARTHREX V-TAK
Manufacturer
ARTHREX, INC.
Date Cleared
2005-03-21

(12 days)

Product Code
HWC
Regulation Number
888.3040
Type
Special
Panel
OR
Reference & Predicate Devices
K022234
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Arthrex V-Tak™ is intended to provide fixation of suture to bone in surgeries of the foot, ankle, hand, wrist, and elbow. Specific indications are listed below:

  • Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction
  • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
  • Foot: Hallux Valgus reconstruction
  • Ankle: Mid-foot reconstruction
Device Description

The Arthrex V-Tak™ is a fully threaded, notched, degradable anchor.

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) K05-0634 for the Arthrex V-Tak™ device does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the format of an AI/ML device study report.

The document is a traditional 510(k) submission for a medical device (a degradable fastener for suture to bone fixation) and focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. It does not involve a study comparing the performance of the device against specific metrics in the way an AI/ML device would.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study as if it were for an AI/ML 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.