Mitek GII Anchor

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

510(k) Number

K953877 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Mitek Drill Guide

  Class I

  FDA 510(k) K892904 Active Cleared 28 Sep 1989

• Mitek Super Quickanchor, Modification

  Class II

  FDA 510(k) K930893 Active Cleared 8 Dec 1993

• Braided Polyester Suture Material

  Class II

  FDA 510(k) K923161 Active Cleared 30 Dec 1992

• Mitek Toggle Anchor(Tm)

  Class II

  FDA 510(k) K950070 Active Cleared 22 May 1995

• Absorbalbe Anchor

  Class II

  FDA 510(k) K944051 Active Cleared 2 Aug 1995

• Mitek Ligament Anchor

  Class II

  FDA 510(k) K926270 Active Cleared 22 Oct 1993

See all devices from Mitek Surgical Products, Inc. →

• What is the primary function of the Mitek GII Anchor?

  The Mitek GII Anchor is designed for the fixation of USP size #0 through #2 suture to bone. It utilizes nitinol wings that deploy under the cortical surface to provide a secure reattachment during surgical procedures.

• What are the surgical requirements for placing this anchor?

  To ensure proper placement of the Mitek GII Anchor, surgeons must prepare a 2.4 mm drill hole in the bone. This specific drill size is necessary to accommodate the anchor's dimensions and allow for the effective deployment of the nitinol wings.

• Is the Mitek GII Anchor compatible with different types of sutures?

  Yes, the device is compatible with multiple suture options. This flexibility allows surgeons to select the appropriate suture material and type to meet specific patient requirements during the reattachment process.

• What is the regulatory status of the Mitek GII Anchor?

  The Mitek GII Anchor has received FDA 510k clearance. 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 surgery.