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K Number
K991151
Device Name
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW
Manufacturer
VILEX, INC.
Date Cleared
1999-04-26

(20 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K991151,K991197
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but is not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.

Device Description

The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant-quality titanium. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation in the human body.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device (Cannulated Screws), not a study report or clinical trial. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

  • Confirming the FDA's review of the 510(k) submission.
  • Stating that the device is substantially equivalent to a legally marketed predicate device.
  • Listing the indications for use of the Vilex/DuVal Cannulated Bone Screw.
  • Describing the materials used (316L implant-quality stainless steel and Ti6Al4V implant-quality titanium).
  • Mentioning the intended use for bone fixation in various surgical contexts.
  • Providing regulatory class and product code.
  • Outlining the manufacturer's responsibilities under the Federal Food, Drug, and Cosmetic Act.

Since the document is a regulatory clearance letter and not a clinical study report, it does not provide the specific data points requested in the prompt.

§ 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.