Vesitec Drill Guide

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931182 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Vesitec Suture Passer

  Class I

  FDA 510(k) K931181 Active Cleared 12 May 1993

• Bone Anchor for Soft Tissue Attachment

  Class II

  FDA 510(k) K932925 Active Cleared 26 Apr 1994

• What types of orthopedic procedures is the Vesitec Drill Guide designed to assist with, and how does it ensure precision in drilling?

  The Vesitec Drill Guide is specifically designed to assist in bone fixation procedures, helping surgeons achieve precise drilling for orthopedic surgeries. Its purpose is to ensure accurate placement of fixation hardware in bone, reducing the risk of misalignment or improper positioning during surgery. The guide’s design likely incorporates alignment features or templates to standardize the drilling process, improving surgical outcomes by maintaining consistency and reducing human error.

• Is the Vesitec Drill Guide intended for reuse, or is it meant to be used only once? How does this affect its sterility and handling?

  The Vesitec Drill Guide is explicitly intended for single-use only, which means it is supplied sterile and should not be reused after a single surgical procedure. This design ensures patient safety by eliminating the risk of cross-contamination or degradation of sterility that could occur with reuse. Clinicians must adhere to single-use protocols, including proper storage and handling to maintain sterility until use.

• What regulatory pathway did the Vesitec Drill Guide follow to gain market authorization in the U.S., and what does this mean for its classification?

  The Vesitec Drill Guide received FDA 510(k) clearance (K931182) through a Traditional 510(k) review, which means it was determined to be substantially equivalent to a legally marketed predicate device. This classification places it in FDA product code JDR under the category *Staple, Fixation, Bone*, and it is categorized as a Class II device by the FDA. The review was conducted by the Orthopedic (OR) Advisory Committee, though no third-party review was involved.

• How should the Vesitec Drill Guide be stored to ensure it remains sterile and functional until use?

  Since the Vesitec Drill Guide is supplied sterile and intended for single-use, it should be stored in its original, unopened packaging in a clean, dry environment protected from physical damage, moisture, or extreme temperatures. The packaging is likely designed to maintain sterility, so any breach (e.g., punctures, contamination) would invalidate its sterile status. Follow manufacturer instructions for storage duration and conditions to preserve its integrity until the time of use.