Mitek Cufftack

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

510(k) Number

K003076 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Mitek Absorbable Toggle Anchor

  Class II

  FDA 510(k) K964013 Active Cleared 24 Feb 1997

• Resolve Quickanchor

  Class II

  FDA 510(k) K993575 Active Cleared 29 Dec 1999

• Mitek Knotless Anchor

  Class II

  FDA 510(k) K974345 Active Cleared 13 Feb 1998

• Mitek Btb Absorbable (Pla) Cross Pin

  Class II

  FDA 510(k) K974341 Active Cleared 16 Apr 1998

• Rididfix 2.7mm Btb Cross Pin Kit

  Class II

  FDA 510(k) K013781 Active Cleared 6 Feb 2002

• BioKnotless Anchor

  Class II

  FDA 510(k) K002639 Active Cleared 11 May 2001

See all devices from Mitek Products →

• What is the primary use of the Mitek Cufftack Handpiece?

  This surgical instrument is designed specifically for rotator cuff repair procedures. It functions as a delivery system to facilitate the fixation of soft tissue anchors to bone during both arthroscopic and open shoulder surgeries.

• How is the Mitek Cufftack supplied?

  The device is supplied as a surgical driver and instrument, identified by model number 251131. It is intended for use as a component of the broader Mitek fixation system in orthopedic surgical settings.

• What is the regulatory status of this device?

  The Mitek Cufftack is subject to FDA 510(k) authorization. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices for its intended use in orthopedic fixation.