DBX Demineralized Bone Matrix Putty, Paste and Mix
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040262 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
DBX Demineralized Bone Matrix Putty, Paste and Mix is a bone graft substitute classified as a demineralized bone matrix under the FDA’s product code MQV. This material is derived from cortical bone through mineral removal, retaining its natural structural properties while promoting osteoconductivity. It is formulated to support bone regeneration in voids or defects where structural integrity is not compromised. The product is designed to be biocompatible and nonhemolytic, ensuring compatibility with autologous blood cells.
The device is supplied in three forms—putty, paste, and a mix—and is intended for use as a bone void filler in orthopedic applications, including extremities, posterolateral spine, pelvis, and cranium. It is supplied as a sterile, single-use product, with the putty formulation incorporating sodium hyaluronate as a carrier. The device is regulated under FDA 510(k) clearance (K040262) and is classified under the Orthopedic Advisory Committee. Storage and handling must comply with sterile medical device protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF DBX Demineralized Bone Matrix 1 - mtfbiologics.org, Dbx Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix ..., PDF DBX Inject. Demineralized Bone Matrix with Delivery System.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040262 | Class II | Active |
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Manufacturer
- Manufacturer
- Musculoskeletal Transplant Foundation
Sources (1)
- FDA 510(k) K040262 24 fields · synced Sep 20, 2026