Cleartrac Cannula

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

510(k) Number

K920454 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Acufex Metal Acl Cannula

  Class II

  FDA 510(k) K932718 Active Cleared 21 Mar 1994

• Acufex Endofix Absorbable Interference Screw

  Class II

  FDA 510(k) K954246 Active Cleared 15 Feb 1996

• Acufex Arthroscopic Shoulder Guide System

  Class II

  FDA 510(k) K940481 Active Cleared 6 May 1994

• Acufex Arthroscopic Shaver

  Class I

  FDA 510(k) K844130 Active Cleared 21 Mar 1985

• Acufex Endobutton System

  Class II

  FDA 510(k) K933948 Active Cleared 21 Jul 1994

• Flouroshield Radiation Reduction Glove

  Class I

  FDA 510(k) K893093 Active Cleared 13 Feb 1990

See all devices from Acufex Microsurgical, Inc. →

• What is the Cleartrac Cannula used for in orthopedic procedures?

  The Cleartrac Cannula is designed as an arthroscope to serve as a conduit for fluid irrigation and visualization during minimally invasive joint surgeries. Its transparent or translucent material improves visibility of internal structures, allowing surgeons to perform precise manipulations without needing additional lighting or imaging aids. This makes it particularly useful in procedures where clear visualization is critical, such as arthroscopic surgeries.

• Is the Cleartrac Cannula intended for single-use or reuse?

  The Cleartrac Cannula is explicitly supplied as a single-use instrument. This design ensures sterility and reduces the risk of cross-contamination between patients, aligning with standard surgical best practices for disposable medical devices. Reuse is not recommended to maintain safety and functionality.

• How should the Cleartrac Cannula be stored to maintain sterility?

  The Cleartrac Cannula must be stored in its original, sealed packaging until use to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Follow standard surgical instrument protocols, such as storing in a sterile barrier pouch or tray, to prevent contamination before use.

• What regulatory pathway was followed for FDA clearance of the Cleartrac Cannula?

  The Cleartrac Cannula received FDA clearance through the traditional 510(k) review pathway, specifically under the classification of Class II. The clearance number is K920454, and it was determined to be substantially equivalent to a predicate device. This pathway ensures that the device meets established safety and effectiveness standards for orthopedic arthroscopic tools.

• Does the Cleartrac Cannula require special handling during orthopedic procedures?

  Yes, the Cleartrac Cannula should be handled with care to avoid damaging its transparent or translucent material, which is essential for optimal visualization. Ensure proper irrigation fluid flow during use to maintain clarity and functionality. Follow manufacturer guidelines for insertion, manipulation, and removal to prevent trauma to surrounding tissues or obstruction of the cannula’s lumen.