Acufex Sterile Cannulated Interference Screw

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

510(k) Number

K900132 ↗

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 primary clinical use for the Acufex Interference Screw?

  This device is designed for the secure attachment of soft tissue grafts within bone tunnels. It is specifically intended for use during orthopedic ligament reconstruction procedures, such as ACL repairs.

• How does the cannulated design assist the surgeon?

  The cannulated design allows the screw to be placed over a guide wire, which facilitates precise positioning of the device within the bone tunnel during orthopedic surgery.

• Is the Acufex Interference Screw supplied ready for surgery?

  Yes, the device is supplied in sterile packaging, which allows for immediate use in the operating room environment.

• What is the regulatory status of this device?

  The Acufex Sterile Cannulated Interference Screw has received FDA 510(k) clearance, as indicated by the K900132 submission record.