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Sign in to claim this brandWhat Orthosoft Inc makes
Orthosoft Inc produces orthopaedic positioning instruments for joint prosthesis implantation, including single-use and reusable guides for shoulder, hip, and knee procedures. Their portfolio also includes robotic surgical navigation systems, osteotomy guides, and application software for radiology image processing and surgical planning. Sterilization containers for reusable devices and joint prosthesis implantation kits are also part of their offerings.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed under the 510(k) and UDI programs. These products are available in the United States, where the manufacturer is based.
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 Orthosoft Inc manufacture?
Orthosoft Inc specializes in orthopaedic devices primarily used during joint prosthesis implantation. Their portfolio includes single-use and reusable positioning instruments for shoulder, hip, and knee surgeries, such as osteotomy guides and joint prosthesis implantation kits. They also develop robotic surgical navigation systems—like the ROSA® platform—and associated software for radiology image processing and surgical planning. Additionally, they produce reusable sterilization containers for their orthopaedic instruments.
Where is Orthosoft Inc based, and where are their devices available?
Orthosoft Inc is headquartered in the United States. Their devices are designed and manufactured there, and they are intended for use within the U.S. regulatory framework. Availability outside the U.S. would depend on local regulatory approvals, which are not addressed in the company’s publicly available information.
Which regulatory registries or programs list Orthosoft Inc’s devices?
Orthosoft Inc’s devices are listed under the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with FDA requirements for medical devices in the U.S. The 510(k) program assesses substantial equivalence to predicate devices, while the UDI system standardizes device identification.
How are Orthosoft Inc’s devices classified under FDA regulations?
Orthosoft Inc’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body area involved (e.g., orthopaedic implants carry higher risk than low-risk positioning instruments).
What distinguishes Orthosoft Inc’s robotic surgical navigation systems from their other products?
Orthosoft Inc’s robotic surgical navigation systems, such as the ROSA® platform, integrate advanced software and hardware to assist surgeons in precise joint prosthesis implantation. Unlike their reusable positioning instruments or osteotomy guides—which are physical tools used during surgery—the robotic systems combine real-time imaging (e.g., DICOM-based radiology data) with robotic guidance to enhance accuracy and reduce human error. This makes them distinct as high-tech solutions requiring both hardware and software validation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zimmer.com
- —
- —
- [email protected]
- Phone
- 1(800)348-2759
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 205670032
Catalogue (207)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Efficient Care 3D Planning | 302.4014 | FDA UDI | Class II | Active |
| iASSIST® Knee System | 302.4021 | FDA UDI | Class II | Active |
| Nexgen, Legacy | 20-8070-004-01 | FDA UDI | Class II | Unknown |
| X-Psi™ | 20-8017-030-00 | FDA UDI | Class II | Active |
| Camera Kit | 20-8000-070-99 | FDA UDI | Class II | Unknown |
| ROSA Hip Software | 20-8060-400-01 | FDA UDI | Class II | Active |
| ROSA Cup Inserter Adaptor | 20-8060-304-00 | FDA UDI | Class II | Active |
| Polaris | 20-8000-070-08 | FDA UDI | Class II | Unknown |
| X-Psi™ | 20-8017-032-00 | FDA UDI | Class II | Active |
| Signature™ Comprehensive® | 20-8090-009-01 | FDA UDI | Class II | Active |
| Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left | 20-8090-003-01 | FDA UDI | Class II | Active |
| ROSA® Recon | 20-8020-110-01 | FDA UDI | Class II | Active |
| Signature ONE Software Package | 302.4018 | FDA UDI | Class II | Active |
| iASSIST | 20-8011-002-00 | FDA UDI | Class II | Active |
| X-Psi™ | 20-8017-035-00 | FDA UDI | Class II | Active |
| ROSA® Shoulder | 20-8087-501-00 | FDA UDI | Class II | Active |
| Trabecular Metal | 20-8075-004-01 | FDA UDI | Class II | Unknown |
| Trabecular Metal | 20-8075-001-01 | FDA UDI | Class II | Unknown |
| iASSIST® | 20-8011-070-19 | FDA UDI | Class II | Active |
| Zimmer Patient Specific Instrument | 305.1004 | FDA UDI | Class II | Unknown |
| Fix Fluted Pin 3.2 x 150 mm Sterile | 20-8000-000-10 | FDA UDI | Class II | Active |
| Universal | 20-8000-020-02 | FDA UDI | Class II | Unknown |
| iASSIST | 20-8011-064-00 | FDA UDI | Class I | Active |
| Rosa® Knee Software Upgrade | 20-8020-140-01 | FDA UDI | Class II | Active |
| Trabecular Metal | 20-8075-004-02 | FDA UDI | Class II | Unknown |
| ROSA Quick Connect Sleeve | 20-8060-002-00 | FDA UDI | Class II | Active |
| Tablet Battery Bay | 20-8060-403-00 | FDA UDI | Class I | Active |
| X-Ray Calibration Strap Short | 20-8017-023-00 | FDA UDI | Class I | Active |
| Nexgen | 20-8000-010-15 | FDA UDI | Class II | Unknown |
| X-Ray Calibration Strap Long | 20-8017-022-00 | FDA UDI | Class I | Active |
| Trabecular Metal | 20-8075-005-00 | FDA UDI | Class II | Unknown |
| Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right | 20-8090-003-02 | FDA UDI | Class II | Active |
| Tablet Power Cord | 20-8060-400-03 | FDA UDI | Class I | Active |
| Sesamoid ® | 20-8000-000-11 | FDA UDI | Class II | Active |
| OptiVu™ Mixed Reality | OVMR-SW-2-0202 | FDA UDI | Class II | Active |
| X-Psi™ Nexgen® | 20-8085-002-02 | FDA UDI | Class II | Active |
| Nexgen | 20-8070-008-02 | FDA UDI | Class II | Unknown |
| Sesamoid | 20-8000-070-35 | FDA UDI | Class II | Unknown |
| OptiVu™ Mixed Reality | OVMR-SW-2-0201 | FDA UDI | Class II | Active |
| ROSA Cup Inserter Screw | 20-8060-305-00 | FDA UDI | Class II | Active |
| Bigliani/Flatow | 20-8075-007-01 | FDA UDI | Class II | Unknown |
| Zimmer Biomet® X-PSITM Knee System | 20-8085-001-01 | FDA UDI | Class II | Active |
| Persona® | 20-8070-011-01 | FDA UDI | Class II | Unknown |
| Navitrak System-Optical Option, Model 900.004 | K002053 | FDA 510(k) | Class II | Active |
| Cas Psi Knee System | K131409 | FDA 510(k) | Class II | Active |
| Navitrack System - Total Hip Replacement Ct-Free | K032917 | FDA 510(k) | Class II | Active |
| Navitrack System Total Hip Replacement, Model 900.200 | K022364 | FDA 510(k) | Class II | Active |
| Navitrack System - Os Unicondylar Knee Universal, Model# Pro-06003 | K071714 | FDA 510(k) | Class II | Active |
| Navitrack | K981315 | FDA 510(k) | Class II | Active |
| Navitrack System: Total Hip Replacement Ct-Free Cup, Model 900.204 | K030827 | FDA 510(k) | Class II | Active |
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