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US
Last updated September 17, 2026
About
Synergy Biomedical - Advancing Biomaterial Technology - optimized bone healing with bioactive glass
From the manufacturer's own website, in their original language. Source
What Synergy Biomedical makes
Synergy Biomedical manufactures synthetic, non-antimicrobial bone matrix implants designed for orthopedic applications. The portfolio includes putty-based and flexible formulations, as well as specialized variants for minimally invasive surgery and extremity use, such as BioSphere Putty and BioSphere Flex SP.
These devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI pathways. The company is based 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 Synergy Biomedical manufacture?
Synergy Biomedical specializes in synthetic, non-antimicrobial bone matrix implants. These devices are primarily used in orthopedic procedures to support bone healing or regeneration. The portfolio includes putty-based formulations like BioSphere Putty and flexible variants such as BioSphere Flex SP, as well as specialized versions for minimally invasive surgery (e.g., BioSphere MIS) and extremity applications (e.g., BioSphere Flex SP Extremities).
Where is Synergy Biomedical based, and what does that mean for its regulatory oversight?
Synergy Biomedical is based in the United States, which means its devices are subject to FDA regulatory requirements. The company’s products fall under the FDA’s Class II classification, indicating they pose moderate risk and require premarket notification (510(k)) or unique device identification (UDI) pathways for authorization. The U.S. location also influences compliance with domestic manufacturing and labeling standards.
Which regulatory registries or databases list Synergy Biomedical’s devices?
Synergy Biomedical’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track authorized medical devices in the U.S., ensuring transparency for healthcare providers, regulators, and patients. The 510(k) pathway demonstrates that each device meets FDA requirements for safety and effectiveness through a comparison to a predicate device.
Why are Synergy Biomedical’s bone matrix implants classified as Class II under FDA regulations?
The FDA categorizes devices based on risk levels, and Synergy Biomedical’s bone matrix implants are classified as Class II because they are not low-risk (Class I) but also do not pose the highest risk (Class III). These implants require special controls beyond general controls to ensure their safety and performance, such as clinical data or performance testing, which is why they must go through the 510(k) or UDI pathways for authorization. Class II classification balances regulatory oversight with the need for these devices in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 565 E. Swedesford Rd, Wayne, PA, 19087
- Website
- www.synergybiomedical.com
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3010258202
- DUNS Number
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Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| BioSphere Putty | 2.5cc | FDA UDI | Class II | Active |
| BioSphere Flex SP | Medium | FDA UDI | Class II | Active |
| BioSphere MIS | Replacement Cannula | FDA UDI | Class II | Active |
| BioSphere Putty | 1cc | FDA UDI | Class II | Active |
| BioSphere Putty | 10cc | FDA UDI | Class II | Active |
| BioSphere Putty | 5cc | FDA UDI | Class II | Active |
| BioSphere MIS Replacement Cannula | BMS-250RC | FDA UDI | Class II | Active |
| BioSphere Flex SP Extremities, Small | BSF-00030 | FDA UDI | Class II | Active |
| BioSphere Putty | 1cc | FDA UDI | Class II | Active |
| BioSphere Flex SP Extremities, Medium | BSF-00040 | FDA UDI | Class II | Active |
| BioSphere Flex, Medium | BSF-25050 | FDA UDI | Class II | Active |
| BioSphere Putty | 10cc | FDA UDI | Class II | Active |
| BioSphere Putty | 5cc | FDA UDI | Class II | Active |
| BioSphere Putty | 2.5cc | FDA UDI | Class II | Active |
| BioSphere MIS | Kit | FDA UDI | Class II | Active |
| BioSphere Flex SP | Large | FDA UDI | Class II | Active |
| BioSphere Flex, Large | BSF-25100 | FDA UDI | Class II | Active |
| BioSphere MIS Kit | BMS-250KT | FDA UDI | Class II | Active |
| BioSphere Putty; BioSphere MIS Putty | K241167 | FDA 510(k) | Class II | Active |
| Biosphere Bioactive Bone Graft Putty, 2.5cc, 5cc, 10cc | K140844 | FDA 510(k) | Class II | Active |
| BioSphere Flex | K173424 | FDA 510(k) | Class II | Active |
| BioSphere MIS Putty (BioSphere MIS) | K173301 | FDA 510(k) | Class II | Active |
| Biosphere Bioactive Bone Graft Putty | K122868 | FDA 510(k) | Class II | Active |
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