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K Number
K973309
Device Name
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
Manufacturer
VILEX, INC.
Date Cleared
1998-01-16

(135 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
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 not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery.

Device Description

The material used to manufacture this screw is 316L, implant-quality stainless steel. 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

I am sorry, but the provided text is a formal letter from the FDA regarding a 510(k) submission for a medical device (Vilex/DuVal Cannulated Bone Screw). It does not contain any information about acceptance criteria, device performance, clinical studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence for the device.
  • Regulatory classifications and requirements.
  • Specific warnings regarding off-label use (pedicular screw fixation).
  • General responsibilities under the Federal Food, Drug, and Cosmetic Act.
  • The intended indications for use as stated by the manufacturer.

§ 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.