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Sign in to claim this brandBiostructures
US
Last updated May 23, 2026
What Biostructures makes
Biostructures manufactures synthetic bone matrix implants designed for orthopedic applications, including the Silhouette and OsteoMatrix products. These devices are intended for use in bone grafting procedures, providing structural support for bone regeneration without antimicrobial properties. The INTERFACE product is also part of their portfolio, likely serving as a specialized bone graft substitute.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) clearance and FDA’s Unique Device Identification (UDI) system. These devices are authorized for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Biostructures manufacture?
Biostructures specializes in synthetic bone matrix implants, specifically non-antimicrobial types. These devices are primarily used in orthopedic applications to support bone regeneration during grafting procedures. Examples include products like Silhouette, OsteoMatrix, and INTERFACE, which serve as substitutes or scaffolds for natural bone.
Where is Biostructures based, and what regulatory registries list its devices?
Biostructures is based in the United States. Its devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identification (UDI) system, which track authorized medical devices for compliance and traceability purposes.
How are Biostructures’ devices classified under FDA regulations?
Biostructures’ devices fall under FDA Class II classification. This category includes moderate-risk medical devices that require special controls beyond general controls to ensure safety and effectiveness, such as bone matrix implants used in orthopedic procedures.
What is the primary intended use of Biostructures’ bone matrix implants?
Biostructures’ bone matrix implants are designed to provide structural support during bone grafting procedures, aiding in the regeneration of bone tissue. They are synthetic and non-antimicrobial, meaning they do not contain agents to fight infection but focus on mechanical integration and biological compatibility.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Silhouette | SIL-090 | FDA UDI | Class II | Active |
| Silhouette | SIL-180 | FDA UDI | Class II | Active |
| OsteoMatrix | OMCS10 | FDA UDI | Class II | Active |
| OsteoMatrix | OMCS05 | FDA UDI | Class II | Active |
| Interface Bone Void Filler | K112857 | FDA 510(k) | Class II | Active |
| MCP Bone Putty | K160446 | FDA 510(k) | Class II | Active |
| Bioactive Bone Graft Putty | K132071 | FDA 510(k) | Class II | Active |
| MCS Bone Graft | K142276 | FDA 510(k) | Class II | Active |
| Interface | K092541 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Biostructures has one FDA recall record initiated on January 31, 2011, which is listed with a terminated status. The recall pertains to the OsteoMatrix Synthetic Bone Graft Composite, specifically noting that the Instructions for Use document (P4G10A/Rev. 01) contained language inconsistent with the cleared indications.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 31, 2011 | Z-1677-2011 | — | terminated | The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications. |