Ortho Guidance Precision Knee Software +3 more models
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233542 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
- Models / Variants
- Ortho Guidance Precision Knee Software FDA 510(k)Ortho Guidance Express Knee Software FDA 510(k)Ortho Guidance Versatile Hip Software FDA 510(k)Q Guidance System 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)
The Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and Q Guidance System are surgical planning and guidance software products. These systems provide guidance, visualization, and data analytics to support decisions surrounding alignment and orientation of instruments, trials, and implants, as well as balancing soft tissue during orthopedic procedures.
The software is intended for use in total knee replacement and hip procedures, enabling less invasive techniques. It is supplied as software for use with the Ortho Q Guidance system. The device has received FDA 510(k) clearance with the product code OLO and is manufactured by Stryker Leibinger GmbH & Co KG in Freiburg Im Breisgau, Germany.
Frequently asked questions
What is the purpose of the Ortho Guidance software?
The Ortho Guidance software is designed to provide surgical planning and guidance for total knee replacement and hip procedures. It offers visualization and data analytics to support decisions on instrument alignment, implant orientation, and soft tissue balancing during orthopedic surgeries.
How is the Ortho Guidance software supplied?
The software is supplied as a digital product for use with the Ortho Q Guidance system. It is not a physical device but rather a software solution that integrates with the guidance system to provide surgical assistance.
What regulatory approvals does the Ortho Guidance software have?
The Ortho Guidance software has received FDA 510(k) clearance with product code OLO. This clearance indicates that the device is substantially equivalent to other legally marketed devices in the United States.
Can the Ortho Guidance software be used for both knee and hip procedures?
Yes, the software includes specific modules for different procedures: Ortho Guidance Precision Knee Software and Ortho Guidance Express Knee Software for knee procedures, and Ortho Guidance Versatile Hip Software for hip procedures.
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 Guidance express knee software - Stryker, Ortho Guidance precision knee software | Stryker, Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233542 | 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) K233542 24 fields · synced Sep 21, 2026