“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130)
Description
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) by Point Robotics MedTech, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241130
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. “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) (K241130) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230087 | "POINT" Kinguide Agile Hybrid Navigation System | Point Robotics MedTech, Inc. | 2023 |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | Medtronic Navigation, Inc. | 2020 |
| K162309 | StealthStation S8 System Platforms and StealthStation Crani... | Medtronic Navigation, Inc. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252989 | "POINT" Kinguide Agile Hybrid Navigation System; DRF Access... | Point Robotics MedTech, Inc. | 2026 |
Trace the full predicate network for K241130
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.