GII QuickAnchor Plus

• • Terminated Z-1626-2013 FDA Class II ·initiated 3 May 2013 ·on shared 510(k) K041115

  The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K041115 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

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  FDA 510(k) K060830 Active Cleared 15 Jun 2006

• Super Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052631 Active Cleared 21 Oct 2005

See all devices from Depuy Mitek, A Johnson & Johnson Company →

• What types of orthopedic procedures is the GII QuickAnchor Plus specifically designed for, and where on the body is it typically used?

  The GII QuickAnchor Plus is designed for soft tissue reattachment to bone in orthopedic procedures, particularly for shoulder, ankle, and foot repairs. Its nitinol wings deploy beneath the cortical surface to secure attachment, making it suitable for stabilizing ligaments, tendons, or other soft tissues in these anatomical regions.

• Is the GII QuickAnchor Plus reusable, or is it intended for single-use only? How does this affect its sterility?

  The GII QuickAnchor Plus is explicitly intended for single-use only, which means it is supplied sterile to ensure patient safety. Since it cannot be sterilized for reuse, each unit must remain unopened until immediate use, adhering to standard sterile medical device protocols.

• What suture size is compatible with the GII QuickAnchor Plus, and how does this influence its clinical application?

  The GII QuickAnchor Plus is designed for USP size 2 suture applications, which is a common size for orthopedic repairs. This compatibility ensures secure fixation of soft tissues to bone, making it versatile for procedures like rotator cuff repairs, ligament reattachments, or tendon repairs in the shoulder, ankle, or foot.

• How should the GII QuickAnchor Plus be stored, and what precautions should be taken to maintain its sterility?

  The GII QuickAnchor Plus must be stored according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile, the packaging should remain unopened until use, and it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation.

• What distinguishes the GII QuickAnchor Plus from other suture anchors, particularly in terms of its deployment mechanism?

  The GII QuickAnchor Plus features nitinol wings that deploy beneath the cortical surface of bone, providing a secure, stable anchor point for soft tissue reattachment. Unlike traditional suture anchors that rely solely on threading or threading mechanisms, this design ensures deeper cortical fixation, which can enhance stability in high-motion joints like the shoulder or ankle.