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InterOss Collagen

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221808

by Sigmagraft, Inc.

Identifiers

510(k) Number
K221808 FDA 510(k)
FDA Product Code
NPM 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 InterOss Collagen Block is a bone grafting material classified as an Animal Source Bone Graft Substitute (per FDA nomenclature). It is an anorganic hydroxyapatite-collagen composite designed to support bone regeneration through osteoconductive properties, providing a scaffold for cell attachment and tissue integration in dental, periodontal, and maxillofacial procedures.

Supplied as a molded block (or plug variant), the device combines 90% bovine-derived hydroxyapatite granules with 10% collagen fibers to mimic the natural mineralized structure of human bone. It is intended for single-use in surgical settings and requires sterile handling. Regulated under FDA 510K (K221808) and MDD, the product adheres to Class II (NPM) device classification (Regulation 872.3930) and is registered for dental applications.

Frequently asked questions

What types of surgical procedures is the InterOss Collagen Block designed to support, and how does its composition help in bone regeneration?

The InterOss Collagen Block is specifically designed for dental, periodontal, and maxillofacial procedures where bone regeneration is required. Its composition—a 90% bovine-derived hydroxyapatite combined with 10% collagen fibers—mimics the natural mineralized structure of human bone, providing an osteoconductive scaffold. This allows cells to attach and integrate, promoting tissue regeneration in areas like bone defects, extractions, or sinus lifts.

Is the InterOss Collagen Block intended for single-use, and what precautions should be taken during handling?

Yes, the InterOss Collagen Block is intended for single-use only, as specified in its design and regulatory classification. Since it requires sterile handling, it should be kept in its sealed packaging until immediately before use. Proper aseptic techniques must be followed to prevent contamination, as the device is not designed for reuse.

What forms does the InterOss Collagen Block come in, and how does the manufacturer ensure consistency across these variants?

The InterOss Collagen Block is supplied as either a molded block or a plug variant, both designed to provide consistent osteoconductive support. The manufacturer maintains uniformity by using a standardized ratio of 90% bovine-derived hydroxyapatite and 10% collagen fibers across all variants, ensuring predictable performance in bone regeneration procedures.

How is the regulatory status of the InterOss Collagen Block defined, and what does this mean for clinicians or buyers?

The InterOss Collagen Block is classified as a Class II (NPM) device under FDA 510K clearance (K221808) and adheres to the Medical Device Directive (MDD). This means it has undergone rigorous review to demonstrate substantial equivalence to a predicate device, ensuring safety and effectiveness for its intended dental applications. Clinicians can rely on its regulatory approval for use in bone grafting procedures.

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: InterOss - SigmaGraft Biomaterials, InterOss® Collagen Block | SigmaGraft Biomaterials, InterOss® Small Granules - shop.sigmagraft.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sigmagraft, Inc.

Sources (2)

  • FDA 510(k) K221808 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026