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Inion BioRestore Biodegradable Bone Graft Substitute

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K090177

by Inion Oy

Identifiers

510(k) Number
K090177 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 Inion BioRestore Biodegradable Bone Graft Substitute is a synthetic bone graft substitute classified under orthopedic nomenclature. It is composed of degradable bioactive glass designed to remodel into natural bone tissue, providing osteoconductive and osteostimulative properties while supporting new bone formation.

This device is supplied in granules and blocks of varying sizes and shapes, intended for use in orthopedic surgical procedures. It is non-sterile as supplied and must be sterilized prior to use, adhering to standard medical device sterilization protocols. Authorized under FDA 510(k) clearance (K090177) and MDD compliance, it is intended for single-use applications in bone defect reconstruction.

Frequently asked questions

What types of bone defects is the Inion BioRestore intended to address in surgical procedures?

The Inion BioRestore Biodegradable Bone Graft Substitute is designed for bone defect reconstruction during orthopedic surgeries. Its bioactive glass composition provides osteoconductive and osteostimulative properties, meaning it supports new bone formation by acting as a scaffold and stimulating bone growth. It is supplied in granules and blocks, making it adaptable for various defect sizes and shapes commonly encountered in orthopedic procedures.

How should the Inion BioRestore be prepared before use in surgery?

The Inion BioRestore is supplied in a non-sterile state, so it must be sterilized prior to use following standard medical device sterilization protocols. This ensures safety and compliance with clinical standards before application in surgical procedures.

Is the Inion BioRestore intended for reuse, or is it meant to be used only once?

The Inion BioRestore is explicitly intended for single-use applications. Its biodegradable and osteoconductive properties are optimized for one-time surgical use in bone defect reconstruction, ensuring consistent performance and safety.

What forms does the Inion BioRestore come in, and how might this affect its use?

The Inion BioRestore is supplied in two forms: granules and blocks of varying sizes and shapes. This versatility allows surgeons to choose the most suitable form for the specific bone defect, whether it requires fine granular fill or a structured block for structural support.

What regulatory pathways does the Inion BioRestore follow, and what does that mean for its use?

The Inion BioRestore is authorized under FDA 510(k) clearance (K090177) and complies with the Medical Device Directive (MDD). This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended single-use orthopedic applications.

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: Inion - Products - BioRestore™ Synthetic Bone Graft Substitute, Bone Grafting - Inion, Inion BioRestore™ - Synthetic Bone Graft Substitute

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inion Oy

Sources (2)

  • FDA 510(k) K090177 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026