Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (K223767)
Description
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System by Stryker Leibinger GmbH & Co KG, an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223767
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (K223767) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022 |
| K162937 | Stryker OrthoMap Versatile Hip System | Stryker Corporation | 2017 |
| K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016 |
| K153240 | Styrker OrthoMap Express Knee System | Stryker Corporate | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Expr... | Stryker Leibinger GmbH & Co KG | 2024 |
Trace the full predicate network for K223767
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.