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Sign in to claim this brandOrtoma AB (Publ)
US
Last updated May 25, 2026
What Ortoma AB (Publ) makes
Ortoma AB (Publ) manufactures electromagnetic/optical surgical navigation systems, including tracking devices and accessories for orthopedic procedures. Their portfolio includes pointer tools, stylets, pins, reamers, inserters, and adapters designed to enhance surgical planning and precision for hip replacements. Solutions like the OTS Hip Series and Emphasys/Pinnacle adapters are tailored for navigation-assisted orthopedic surgeries.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Ortoma AB (Publ) 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 Ortoma AB (Publ) primarily manufacture?
Ortoma AB (Publ) specializes in electromagnetic and optical surgical navigation systems. Their devices include tracking systems, pointer tools (like the Pointer OT), stylets, pins, reamers, and various adapters (e.g., Reamer Adapter OTD, Inserter Adapter OTD). These tools are designed to assist in surgical planning and enhance precision during orthopedic procedures, particularly hip replacements. The company’s portfolio focuses on improving navigation and tracking for safer, more accurate surgeries.
Where is Ortoma AB (Publ) based, and what is its primary market focus?
Ortoma AB (Publ) is based in the United States. While the company name includes 'AB (Publ),' indicating a publicly listed corporation in Sweden, its operational focus and device manufacturing align with the US market. The company’s devices are tailored for orthopedic surgeries, specifically electromagnetic/optical navigation systems used in hip replacements and related procedures.
Which regulatory registries or databases list Ortoma AB (Publ)’s devices?
Ortoma AB (Publ)’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the US. The inclusion in the UDI database reflects the company’s adherence to FDA requirements for Class II devices, which are subject to performance standards and post-market surveillance.
How are Ortoma AB (Publ)’s devices classified under FDA regulations?
Ortoma AB (Publ)’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices undergo rigorous review to validate their performance, labeling, and manufacturing processes before authorization. Examples like the OTS Hip Series and navigation-enhancement tools are designed to reduce surgical risks in orthopedic procedures, aligning with the regulatory expectations for this category.
What is the purpose of Ortoma AB (Publ)’s navigation-enhancement systems in orthopedic surgeries?
Ortoma AB (Publ)’s navigation-enhancement systems, such as the OTS Hip Series and adapters (e.g., Emphasys, Pinnacle), are engineered to improve surgical precision during hip replacements. These systems combine electromagnetic or optical tracking with specialized tools (e.g., pointers, stylets) to guide surgeons in real-time, reducing human error and optimizing implant placement. By integrating planning and intraoperative navigation, the devices aim to enhance outcomes while minimizing complications in complex orthopedic procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 633151436
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pointer OT | 1002 | EUDAMEDFDA UDI | Class II | Active |
| Stylet and Pin | 1003 | EUDAMEDFDA UDI | Class II | Active |
| Reamer Adapter OTD | 1003 | FDA UDI | Class II | Active |
| Inserter Adapter OTD Straight | 1002 | EUDAMEDFDA UDI | Class II | Active |
| OTS Hip Solution Emphasys | 1001 | FDA UDI | Class II | Active |
| OTS Hip Solution Pinnacle | 1001 | FDA UDI | Class II | Active |
| Attachment Adapter Fix OT | 1002 | EUDAMEDFDA UDI | Class II | Active |
| Inserter Adapter OTD | 1004 | EUDAMEDFDA UDI | Class II | Active |
| Calibration Adapter Unit OTD Emphasys | 1002 | EUDAMEDFDA UDI | Class II | Active |
| OTS Hip | 1001 | FDA UDI | Class II | Active |
| Inserter Adapter OTD Pinnacle Straight | 1001 | EUDAMEDFDA UDI | Class II | Active |
| OTS Hip Plan | 5 | EUDAMEDFDA UDI | Class II | Active |
| Threaded Pin Driver | 1004 | EUDAMEDFDA UDI | Class II | Active |
| Measurement Screw Driver | 1002 | EUDAMEDFDA UDI | Class II | Active |
| Threaded Pin 4x150 mm | 1001 | EUDAMEDFDA UDI | Class II | Active |
| Attachment Adapter Twin OT | 1006 | EUDAMEDFDA UDI | Class II | Active |
| OTS Hip Guide Reusable Set Emphasys | 1001 | FDA UDI | Class II | Active |
| OTS Hip Guide SW | 5 | FDA UDI | Class II | Active |
| Pointer Holder | 1002 | EUDAMEDFDA UDI | Class II | Active |
| OTS Hip Guide Reusable Set Pinnacle | 1001 | FDA UDI | Class II | Active |
| Tracer Set | 1001 | EUDAMEDFDA UDI | Class II | Active |
| Calibration Adapter Unit OTD | 1003 | FDA UDI | Class II | Active |
| Measurement Screw 8 mm | 1001 | EUDAMEDFDA UDI | Class II | Active |
| Measurement Screw 15 mm | 1001 | EUDAMEDFDA UDI | Class II | Active |
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