Acufex Interference Screw and Screwdriver

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

510(k) Number

K883910 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

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 Acufex Interference Screw and Screwdriver used for?

  The Acufex Interference Screw and Screwdriver is a surgical device designed to fixate soft tissue grafts to bone during ligament reconstruction surgeries, such as ACL repairs. It provides secure placement of the graft to promote proper healing post-surgery.

• How is the Acufex Interference Screw supplied?

  The device is supplied as a sterile, single-use system. It is available in various sizes to accommodate different surgical needs. Each unit is intended for one-time use only to ensure patient safety and device integrity.

• What regulatory approvals does the Acufex Interference Screw have?

  The Acufex Interference Screw and Screwdriver received FDA 510(k) clearance on October 12, 1988, with product code HWC. It is classified as substantially equivalent and is intended for use in orthopedic procedures, but is not intended for MRI environments.

• Can the Acufex Interference Screw be reused?

  No, the Acufex Interference Screw and Screwdriver is designed as a single-use system. Reusing the device could compromise its structural integrity and sterility, potentially leading to surgical complications or patient infection.