PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (K222381)
Description
PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System by Stryker GmbH, an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
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Predicate lineage for K222381
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. PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (K222381) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 |
| K192217 | NCB Plating System Distal Femur and Proximal Tibia | Zimmer GmbH | 2019 |
| K172262 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | 2017 |
| K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, ... | Stryker GmbH | 2023 |
Trace the full predicate network for K222381
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.