Ortho-Map-Oncology Navigation Software, Models 6005-650-000, 6005-651-000
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K083009 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ortho-Map Oncology Navigation Software is a computer-assisted surgical planning and navigation system designed for orthopedic oncology procedures. It enables segmentation and visualization of multi-modality imaging data to define volumes of interest, such as bony structures, for precise surgical planning and guidance during intervention.
The software is supplied as a digital product for use in sterile surgical environments, compatible with navigation systems for orthopedic oncology. It is classified as an orthopedic stereotaxic instrument under FDA regulation 882.4560 and holds a traditional 510(k) clearance (K083009) for substantial equivalence. Models 6005-650-000 and 6005-651-000 are intended for integration with compatible hardware platforms.
Frequently asked questions
What types of orthopedic oncology procedures is this software designed to assist with?
The Ortho-Map Oncology Navigation Software is specifically designed to assist with surgical planning and intraoperative guidance for orthopedic oncology procedures. It integrates multi-modality imaging data to help surgeons visualize and define critical volumes of interest, such as bony structures affected by tumors, ensuring precise surgical intervention.
How is this software supplied, and where is it intended to be used?
The software is supplied as a digital product and is intended for use in sterile surgical environments. It is compatible with navigation systems tailored for orthopedic oncology procedures, meaning it requires integration with compatible hardware platforms to function effectively during surgery.
Are there different models of this software, and how do they differ?
Yes, there are two models: 6005-650-000 and 6005-651-000. While the exact functional differences between them are not detailed in the specifications, both are designed for integration with compatible hardware platforms to support orthopedic oncology navigation during surgical procedures.
What regulatory pathway was followed for clearance of this software?
The Ortho-Map Oncology Navigation Software received a traditional 510(k) clearance (K083009) under the FDA’s substantially equivalent pathway. It is classified under FDA regulation 882.4560 as an orthopedic stereotaxic instrument and was reviewed by the Orthopaedics Devices Panel (OR).
Does this software require any specific hardware to operate?
Yes, the software is designed for integration with compatible navigation systems specifically developed for orthopedic oncology procedures. It is not a standalone product but rather a digital tool that enhances surgical planning and guidance when paired with the appropriate hardware platform.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ortho-map-oncology Navigation Software, Models 6005-650-000, 6005-651-000, PDF Ortho-map-oncology Navigation Software, Models 6005-650-000, 6005-651 ..., Ortho-map-oncology Navigation Software, Models 6005-650-000, 6005-651-000
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083009 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Leibinger Gmbh & Co. Kg
- FDA Applicant
- Stryker Leibinger GmbH & Co KG
Sources (1)
- FDA 510(k) K083009 24 fields · synced Sep 19, 2026