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0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161996

by Amend Surgical, Inc.

Identifiers

510(k) Number
K161996 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)

The NanoFUSE is a malleable, putty-like bone void filler composed of 45S5 bioactive glass particles coated with porcine gelatin. Designed as an orthopedic device, it is intended for filling and stabilizing bone defects or voids, promoting osseointegration through its bioactive properties. The formulation supports natural bone healing by integrating with surrounding tissue over time. Available in five distinct volumes, it provides flexibility for varying clinical scenarios requiring precise volume control.

Supplied sterile and dry in a syringe, NanoFUSE is reconstituted at the point of use by the surgeon using sterile saline, water for injection, or autologous whole blood. The device is classified as FDA Class II and holds a Traditional 510(k) clearance under product code MQV, with a decision date of February 16, 2017. It is intended for single-use applications in orthopedic procedures, requiring careful handling and storage in accordance with sterile medical device protocols.

Frequently asked questions

What is the NanoFUSE bone void filler used for?

The NanoFUSE is designed to fill and stabilize bone defects or voids during orthopedic procedures. Its bioactive glass composition integrates with surrounding tissue, supporting natural bone healing and osseointegration over time. This makes it ideal for scenarios requiring precise volume control, such as gap filling or defect reconstruction.

How is NanoFUSE supplied and prepared for use?

NanoFUSE is supplied sterile and dry in a syringe. At the point of use, the surgeon reconstitutes it by mixing with sterile saline, water for injection, or autologous whole blood. This ensures proper consistency for application while maintaining sterility.

Is NanoFUSE intended for single-use or reuse?

NanoFUSE is classified for single-use only. Due to its sterile packaging and bioactive formulation, reuse is not recommended to prevent contamination or compromise clinical outcomes. Always follow sterile medical device protocols during handling.

What sizes or volumes are available for NanoFUSE?

NanoFUSE is available in five distinct volumes: 0.5cc, 1.0cc, 2cc, 5cc, and 10cc. This range allows clinicians to select the appropriate volume based on the specific bone defect or void they are addressing, ensuring flexibility in orthopedic procedures.

How should NanoFUSE be stored before use?

NanoFUSE must be stored in accordance with sterile medical device protocols. The dry, sterile syringe packaging should be kept in a clean, dry environment, protected from moisture and contamination. Always check expiration dates and follow manufacturer guidelines to maintain sterility until reconstitution.

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: 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE, 0.5cc Nanofuse, 1.0cc Nanofuse, 2cc Nanofuse, 5cc Nanofuse, 10cc ..., 0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Amend Surgical, Inc.

Sources (1)

  • FDA 510(k) K161996 24 fields · synced Oct 1, 2026