Class Class II
Xpert Knee (K250155)
Description
Xpert Knee by Newclip Technics, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250155
Clearance Date2025-04-23
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250155
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. Xpert Knee (K250155) cites 7 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241539 | Activmotion S | Newclip Technics | 2024 |
| K221395 | Footmotion Plating System | Newclip Technics | 2022 |
| K173746 | Activmotion Range | Newclip Technics | 2018 |
| K120689 | SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM | Synthes (USA) Products, LLC | 2012 |
| K082624 | SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES | Synthes (Usa) | 2008 |
| K050646 | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES | Synthes (Usa) | 2005 |
| K030597 | SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES | Synthes (Usa) | 2003 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261511 | Xpert Ankle | Newclip Technics | 2026 |
| K253906 | Xpert Hand | Newclip Technics | 2026 |
Trace the full predicate network for K250155
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.