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Surfuse Ii Gel, Surfuse Ii Putty, Exfuse Ii Gel, Exfuse Ii Putty

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130235

by Hans Biomed Corp.

Identifiers

510(k) Number
K130235 FDA 510(k)
FDA Product Code
NUN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, and Exfuse II Putty are human allograft-derived bone void fillers classified as Bone Grafting Material, Human Source. These products are processed from human bone tissue, demineralized via hydrochloric acid, and combined with a carboxymethylcellulose carrier to create a putty or gel formulation for clinical use.

These materials are intended for use as bone void fillers in bony gaps or voids that do not compromise skeletal stability, typically applied in the extremities and pelvis. Supplied in sterile form for single-use, they are regulated under FDA 510(k) clearance (K130235) as Class II devices under product code NUN. Storage and handling follow standard sterile medical device protocols to maintain integrity and efficacy.

Frequently asked questions

What are Surfuse II Gel and Putty intended clinical uses?

Surfuse II Gel and Putty are designed to fill bony gaps or voids that do not compromise skeletal stability. They are primarily used in the extremities and pelvis to support bone healing without requiring structural support. The products are processed from human bone tissue, demineralized with hydrochloric acid, and combined with a carboxymethylcellulose carrier to create a stable, resorbable filler.

How are these products supplied and what is their sterility status?

Surfuse II Gel and Putty are supplied in sterile form, ensuring they are ready for immediate clinical use without additional sterilization. Each package is intended for single-use only to maintain sterility and prevent contamination. This aligns with standard sterile medical device protocols to preserve efficacy and safety.

Are Surfuse II and Exfuse II products reusable or single-use?

These products are explicitly designed for single-use only. Reusing them could compromise sterility, integrity, and clinical safety. The packaging and processing ensure they remain sterile and effective for one application, adhering to best practices for allograft-derived materials.

What storage and handling requirements apply to these bone void fillers?

Surfuse II and Exfuse II products must be stored following standard sterile medical device protocols to maintain their integrity and efficacy. This includes keeping them in a clean, dry environment, protected from moisture and extreme temperatures. Always refer to the packaging instructions for specific storage conditions, as improper handling could degrade the product’s performance.

How are these products regulated and approved?

Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, and Exfuse II Putty are regulated under the FDA’s 510(k) clearance process as Class II devices under product code NUN. They were cleared as substantially equivalent to a predicate device through a traditional review pathway by the Dental (DE) Advisory Committee. The clearance number is K130235.

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: Surfuse Ii Gel, Surfuse Ii Putty, Exfuse Ii Gel, Exfuse Ii Putty ..., K130235 FDA 510 (k) - SURFUSE II GEL | Hans Biomed Corp., SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hans Biomed Corp.

Sources (1)

  • FDA 510(k) K130235 24 fields · synced Oct 1, 2026