Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
by Medtronic Sofamor Danek, Inc.
510(k) K251193
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251193 | Date12 Jun 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MQV
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Grafton DBM; Grafton Plus DBM Paste; and Magnifuse Bone Graft are demineralized bone matrix products designed as bone graft substitutes. These devices provide an osteoinductive scaffold derived from donor bone, facilitating bone regeneration and fusion through natural healing processes. They are classified under orthopedic bone graft substitutes, offering structural support and promoting new bone formation in surgical applications. Each formulation is engineered to enhance osteoconductivity while maintaining biocompatibility with host tissue.
These products are supplied as single-use, ready-to-use materials in sterile, single-patient containers. Grafton DBM is provided in a dry form, while Grafton Plus DBM Paste is a pre-mixed consistency for easier application. Magnifuse Bone Graft is intended for use in spine and trauma surgeries, adhering to FDA 510(k) clearance under the product code MQV. Storage and handling follow standard sterile processing protocols to preserve integrity until surgical use.
Other devices from Medtronic Sofamor Danek, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Grafton DBM products used for in surgical applications?
The Grafton DBM, Grafton Plus DBM Paste, and Magnifuse Bone Graft are designed as bone graft substitutes to facilitate bone regeneration and fusion. They provide an osteoinductive scaffold derived from donor bone, offering structural support and promoting new bone formation through natural healing processes. These products are particularly suited for orthopedic applications where bone regeneration is required, such as in spine and trauma surgeries.
How are these bone graft substitutes supplied, and what form do they come in?
The Grafton DBM is supplied in a dry form, while the Grafton Plus DBM Paste comes pre-mixed for easier application. Magnifuse Bone Graft is specifically formulated for spine and trauma surgeries. All products are provided in sterile, single-use, single-patient containers to ensure safety and efficacy during surgical procedures.
Are these products single-use or reusable, and how should they be stored?
These products are intended for single-use only, with each container designed for one patient to maintain sterility and prevent contamination. Storage and handling must follow standard sterile processing protocols to preserve the integrity of the materials until they are ready for surgical use. Always refer to the manufacturer’s guidelines for specific storage instructions.
What distinguishes Magnifuse Bone Graft from the other Grafton products?
Magnifuse Bone Graft is specifically engineered for use in spine and trauma surgeries, adhering to FDA 510(k) clearance under the product code MQV. While Grafton DBM and Grafton Plus DBM Paste are versatile bone graft substitutes, Magnifuse is tailored for applications requiring precise adhesion and support in spinal and trauma procedures, ensuring enhanced osteoconductivity and biocompatibility.
Why is sterility important for these bone graft substitutes, and how is it ensured?
Sterility is critical for bone graft substitutes to prevent infection and ensure successful integration with host tissue. These products are manufactured and packaged in sterile, single-patient containers to eliminate contamination risks. The sterile barrier is maintained throughout storage and handling, following strict protocols to preserve the product’s integrity until it is used in surgery.