Mitek G III Anchor, Mitek LS Anchor

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

510(k) Number

K944936 ↗

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 are the Mitek G III and LS Anchors used for?

  These anchors are designed to stabilize bone by securing soft tissue or bone fragments to bone surfaces. They provide mechanical stability during the healing process, making them ideal for orthopedic procedures such as joint repairs or ligament reconstructions. Their construction ensures a secure attachment, helping to maintain proper alignment and promote effective recovery.

• Are the Mitek G III and LS Anchors supplied sterile and for single-use?

  Yes, the Mitek G III and LS Anchors are supplied sterile and intended exclusively for single-use in surgical settings. This ensures patient safety by preventing contamination and cross-infection, as well as maintaining the integrity of the device for optimal performance during the procedure.

• How are these anchors distributed, and what surgical kits include them?

  The Mitek G III and LS Anchors are distributed as part of orthopedic surgical kits. They are packaged and supplied in a manner that aligns with standard surgical practices, ensuring they are readily available for use in procedures requiring secure fixation of soft tissue or bone fragments to bone surfaces.

• What regulatory pathway do the Mitek G III and LS Anchors follow?

  These anchors are regulated under the FDA 510(k) clearance process, specifically with clearance number K944936. They are classified under product code JDR as staples for bone fixation and are determined to be substantially equivalent to a predicate device, as reviewed by the Orthopedic Advisory Committee.

• Are there any specific size or model variations for these anchors?

  The Mitek G III and LS Anchors are differentiated by their model designations (G III and LS), which likely correspond to variations in size, shape, or intended application. While the exact specifications for each model are not detailed in the provided data, the G III and LS variants are tailored for specific orthopedic fixation needs, ensuring compatibility with various surgical requirements.