Mini QuickAnchor and QuickAnchor Plus with OrthoCord
by Depuy Mitek, A Johnson & Johnson Company
510(k) K071257
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071257 | Date29 Jun 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mini QuickAnchor and QuickAnchor Plus with OrthoCord are orthopedic fixation devices designed for soft tissue and tendon reattachment. These devices feature a miniaturized anchor system with an integrated OrthoCord suture loop, enabling secure attachment of tendons or ligaments to bone. The QuickAnchor Plus variant incorporates an enhanced design for improved pull-out resistance and ease of use in delicate procedures. Both devices are intended for use in orthopedic surgeries requiring stable fixation in small or confined anatomical spaces.
The Mini QuickAnchor and QuickAnchor Plus are supplied sterile and intended for single-use only. They are regulated under the FDA’s 510(k) clearance process, classified under the Orthopedic advisory committee (OR) with a traditional review pathway. The devices are available in specific sizes and configurations as detailed in the specifications, requiring proper surgical technique for implantation. Storage must adhere to sterile packaging instructions to maintain integrity until use. No additional regulatory approvals beyond the stated FDA clearance are implied.
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Questions
AI-generated answers, 1 Oct 2026
What are the Mini QuickAnchor and QuickAnchor Plus with OrthoCord used for?
These devices are designed for soft tissue and tendon reattachment in orthopedic surgeries. The Mini QuickAnchor and QuickAnchor Plus with OrthoCord provide secure fixation of tendons or ligaments to bone, particularly in small or confined anatomical spaces. The QuickAnchor Plus variant includes an improved design for better pull-out resistance and ease of use during delicate procedures.
How are the Mini QuickAnchor and QuickAnchor Plus with OrthoCord supplied and prepared for use?
Both devices are supplied sterile and intended for single-use only. They come in sterile packaging, and proper adherence to these packaging instructions is essential to maintain sterility until the time of use. This ensures the devices remain uncontaminated and ready for surgical application.
Are there different sizes or configurations available for these anchors?
Yes, the Mini QuickAnchor and QuickAnchor Plus with OrthoCord are available in specific sizes and configurations as detailed in the manufacturer’s specifications. The exact variations are intended to accommodate different surgical needs, particularly in procedures requiring precise fixation in smaller or confined areas.
How should these devices be stored before use?
Storage must follow the manufacturer’s instructions for sterile packaging to preserve the integrity of the devices. This includes keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until immediately before use.
What regulatory pathway applies to the Mini QuickAnchor and QuickAnchor Plus with OrthoCord?
These devices are regulated under the FDA’s 510(k) clearance process, classified under the Orthopedic advisory committee (OR) with a traditional review pathway. The FDA determined them to be substantially equivalent to a predicate device, granting clearance for commercial distribution in the U.S.