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NovaBone Putty – Bioactive Synthetic Bone Graft

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K110368

by NovaBone Products, LLC

Identifiers

510(k) Number
K110368 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 NovaBone Putty – Bioactive Synthetic Bone Graft is a synthetic bone graft substitute classified under the FDA’s product code MQV (Orthopedic Devices, Bone Graft Substitutes). It is designed as a bioactive material intended to support bone regeneration and healing by promoting osteoconductivity and osseointegration through its chemical composition of calcium phosphosilicate, mimicking natural bone elements like silicon, sodium, and calcium.

This putty is supplied in a sterile, single-use format for surgical applications in orthopedic procedures. It is intended for use in bone defect sites, including spinal fusion, trauma repair, and periodontal regeneration, where bone grafting is required. The device is regulated under FDA 510(k) clearance (K110368) and complies with the Medical Device Directive (MDD). Storage and handling must adhere to sterile surgical protocols to maintain efficacy.

Frequently asked questions

What types of surgical procedures is NovaBone Putty primarily used for, and how does its composition support bone regeneration?

NovaBone Putty is primarily used in orthopedic procedures such as spinal fusion, trauma repair, and periodontal regeneration where bone grafting is required. Its bioactive composition of calcium phosphosilicate mimics natural bone elements like silicon, sodium, and calcium, promoting osteoconductivity and osseointegration. This chemical structure helps support bone regeneration and healing by encouraging new bone growth at defect sites.

Is NovaBone Putty intended for single-use only, and if so, why is this important for surgical settings?

Yes, NovaBone Putty is supplied in a sterile, single-use format. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical in surgical settings where infection control is paramount. Single-use also guarantees the material’s efficacy, as reuse could compromise its bioactive properties and structural integrity.

How should NovaBone Putty be stored, and what precautions must be taken to preserve its sterility and effectiveness?

NovaBone Putty must be stored following sterile surgical protocols to maintain its efficacy. Since it is sterile and single-use, it should be kept in a sealed, uncontaminated environment, protected from moisture and physical damage. Proper storage ensures the bioactive properties of the calcium phosphosilicate remain intact until use, preventing degradation or loss of performance.

What regulatory pathways does NovaBone Putty follow, and what does this mean for clinicians or hospitals considering its use?

NovaBone Putty is regulated under the FDA’s 510(k) clearance process (K110368) and complies with the Medical Device Directive (MDD). This means the device has undergone evaluation by the FDA to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for bone graft substitutes. Clinicians or hospitals can rely on this regulatory clearance as evidence of the product’s compliance with stringent medical device requirements.

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: Reforming Patients Futures - NovaBone, Aktion NovaBone – Die nächste Generation synthetischer Kn, Our Products for 2026 - NovaBone, NovaBone Putty™ | bei Kröner Medizintechnik - kroener-medical.de, Novabone® - Via 4 Spine Wirbelsäulenchirurgie

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
NovaBone Products, LLC

Sources (2)

  • FDA 510(k) K110368 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026