QuickAnchor, Modification

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

510(k) Number

K921873 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

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 QuickAnchor Modification designed for?

  The QuickAnchor Modification is a cortical fixation device intended specifically for securing soft tissue to bone. Its design ensures stable reattachment during orthopedic and sports medicine procedures, such as ligament or tendon repairs, by deploying beneath the cortical surface for enhanced grip and stability. The titanium alloy base and nitinol wings work together to provide versatile suture attachment options, accommodating various surgical needs.

• How is the QuickAnchor Modification supplied and intended for use?

  The QuickAnchor Modification is supplied as a single-use orthopedic implant. It is intended exclusively for sterile surgical environments, where it is implanted directly into bone. Due to its single-use nature, it cannot be reused or reprocessed, and proper sterile handling and storage are critical to maintain its integrity and functionality.

• What materials is the QuickAnchor Modification made from?

  The QuickAnchor Modification is constructed from a titanium alloy base combined with nitinol wings. The titanium alloy provides durability and biocompatibility, while the nitinol wings enhance grip beneath the cortical surface, ensuring secure fixation. This material combination supports its use in demanding orthopedic and sports medicine applications.

• Is the QuickAnchor Modification reusable or intended for MRI compatibility?

  No, the QuickAnchor Modification is explicitly designed for single-use only and is not intended for reuse. Additionally, it is not labeled for MRI compatibility, meaning it should not be used in MRI environments unless specifically cleared for such use by the manufacturer or regulatory bodies. Always verify compatibility with imaging equipment before use.

• What regulatory pathway does the QuickAnchor Modification follow?

  The QuickAnchor Modification has received FDA clearance under the Traditional 510(k) pathway with clearance number K921873. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for orthopedic implants in the United States. No additional regulatory markings beyond this clearance are referenced.