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Sign in to claim this brandOrthosonics, Ltd.
US
Last updated May 23, 2026
What Orthosonics, Ltd. makes
Orthosonics, Ltd. manufactures ultrasonic and electric orthopaedic cement extractors designed for removing bone cement from surgical sites. These devices are primarily used in orthopaedic procedures to assist in the removal of polymethylmethacrylate (PMMA) without damaging surrounding tissues.
The company’s portfolio is classified under FDA Class II devices and is authorised through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. The devices are listed in the FDA’s regulatory databases, and the manufacturer 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 Orthosonics, Ltd. manufacture?
Orthosonics, Ltd. specializes in devices used for orthopaedic surgery, specifically ultrasonic and electric orthopaedic cement extractors. These devices are designed to remove bone cement, such as polymethylmethacrylate (PMMA), from surgical sites during or after procedures. The focus is on minimizing tissue damage while ensuring efficient extraction.
Where is Orthosonics, Ltd. based, and what does that mean for its regulatory oversight?
Orthosonics, Ltd. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). Since the company’s products are classified as Class II devices, they require premarket notification (510(k)) clearances and must comply with FDA regulations, including the Unique Device Identification (UDI) system.
Which regulatory registries or databases list Orthosonics, Ltd.’s devices?
Orthosonics, Ltd.’s devices are listed in the FDA’s regulatory databases, specifically through 510(k) clearances and the FDA’s Unique Device Identification (UDI) system. These registries ensure transparency and traceability of the devices in the U.S. market, allowing healthcare providers and regulators to verify compliance and device details.
How are Orthosonics, Ltd.’s devices classified by regulatory authorities?
Orthosonics, Ltd.’s devices are classified as FDA Class II under U.S. regulations. This classification indicates that while they pose moderate risk, they still require specific controls—such as 510(k) clearances—to ensure safety and effectiveness. Class II devices are subject to stricter oversight than Class I but less than Class III, balancing regulatory scrutiny with operational feasibility.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (53)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar | 1 | FDA UDI | Class II | Active |
| Oscar, Model Oe3000db | K051053 | FDA 510(k) | Class II | Active |
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