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DBX Strip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042829

by Musculoskeletal Transplant Foundation

Identifiers

510(k) Number
K042829 FDA 510(k)
FDA Product Code
MBP 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)

The DBX Strip is a demineralized bone matrix filler classified as a bone void filler for osteoinduction without human growth factors. It is designed to fill bone defects and support natural bone regeneration by providing a scaffold for cellular ingrowth and new bone formation.

This device is supplied as a sterile, single-use product intended for orthopedic applications. It is regulated under 21 CFR 888.3045 and has received FDA 510(k) clearance (K042829) as substantially equivalent to a predicate device. The strips are packaged for surgical use and must be handled under aseptic conditions.

Frequently asked questions

What types of bone defects is the DBX Strip designed to address in orthopedic procedures?

The DBX Strip is specifically designed as a bone void filler to address bone defects where natural bone regeneration is needed. It acts as a scaffold for cellular ingrowth, promoting osteoinduction—meaning it encourages the body’s own cells to form new bone—without relying on external human growth factors. This makes it suitable for filling gaps or cavities in bone during orthopedic surgeries where structural support and regeneration are required.

How is the DBX Strip supplied, and what precautions should be taken during handling?

The DBX Strip is supplied as a sterile, single-use product, meaning each package is intended for one surgical procedure only. Since sterility is critical, it must be handled under aseptic conditions to prevent contamination. The packaging is designed for surgical use, so proper sterile technique—such as using gloves, sterile instruments, and maintaining a clean field—is essential to preserve its integrity before and during implantation.

Is the DBX Strip reusable, or is it intended for one-time surgical use?

The DBX Strip is explicitly labeled as a single-use device, meaning it is not intended for reuse after a single surgical procedure. This classification aligns with its sterile packaging and the risk of microbial contamination if reprocessed, which could compromise patient safety and efficacy.

What regulatory pathway was followed for FDA clearance of the DBX Strip, and how does this affect its use?

The DBX Strip received FDA 510(k) clearance (K042829) under the Traditional review pathway, demonstrating it is substantially equivalent to a predicate device already on the market. This clearance confirms its compliance with FDA standards for bone void fillers used in orthopedic procedures, ensuring it meets safety and effectiveness requirements for its intended use as described in the labeling.

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 Strip. Demineralized Bone Matrix. - mtfbiologics.org, PDF DBX Strip. Demineralized Bone Matrix. - mtfbiologics.org, DBX STRIP (K042829) — FDA 510(k) | Innolitics, DBX STRIP - Musculoskeletal Transplant Foundation Trademark Registration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Musculoskeletal Transplant Foundation

Sources (1)

  • FDA 510(k) K042829 24 fields · synced Sep 19, 2026