Memometal Bone Anchors
510(k) K071941
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071941 | Date4 Dec 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- Withdrawn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
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Memometal Bone Anchors are orthopedic fixation devices designed for ligamentous tissue attachment to bone. These anchors provide a secure method for ligament restoration by integrating with bone tissue, ensuring stable fixation during healing processes.
These anchors are supplied as single-use devices and are intended for use in orthopedic surgical procedures. They are classified under FDA Product Code HWC and were granted a Traditional 510(k) clearance (K071941) under the FDA’s orthopedic advisory committee. No specific MRI safety information is provided, and they are not intended for reusable applications.
Other devices from Memometal Technologies
Questions
AI-generated answers, 19 Sep 2026
Are these bone anchors intended for use in specific types of orthopedic surgeries, and what makes them suitable for ligament restoration?
The Memometal Bone Anchors are designed specifically for ligamentous tissue attachment to bone, making them suitable for ligament restoration procedures. Their unique design integrates with bone tissue, providing a secure and stable fixation during the healing process. This is particularly useful in surgeries where ligament repair or reconstruction is required, such as ACL or other tendon/ligament repairs.
How are the Memometal Bone Anchors supplied, and are they reusable?
The Memometal Bone Anchors are supplied as single-use devices, meaning each anchor is intended for one surgical procedure only. This design choice ensures sterility and reduces the risk of cross-contamination or infection, which is critical in orthopedic surgeries. Reuse is explicitly not recommended for these anchors.
What should I consider when storing these bone anchors, and are there any special handling instructions?
Since the Memometal Bone Anchors are single-use and sterile, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use to maintain sterility. Always follow the manufacturer’s instructions for storage and handling to ensure optimal performance and safety.
Are there different sizes or models of these bone anchors, and how would I determine the right fit for a patient?
The provided data does not specify exact sizes or models of the Memometal Bone Anchors, so you would need to consult the manufacturer’s product documentation or catalog for detailed sizing information. Typically, orthopedic anchors come in various sizes to accommodate different bone diameters and ligament thicknesses. Your choice should be based on the specific surgical requirements and anatomical considerations of the patient, often guided by the surgeon’s discretion.