Class Class II
Knotilus+ Biocomposite Knotless Anchor (K250544)
Description
Knotilus+ Biocomposite Knotless Anchor by Stryker Endoscopy, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250544
Clearance Date2025-05-23
Clearance TypeTraditional
Product CodeMAI
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250544
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. Knotilus+ Biocomposite Knotless Anchor (K250544) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment C... | 2023 |
| K231093 | AlphaVent Suture Anchors | Stryker Endoscopy | 2023 |
| K201786 | Arthrex Mini Hip PushLock | Arthrex, Inc. | 2020 |
| K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018 |
| K151092 | Arthrex Short Suture Anchors | Arthrex, Inc. | 2016 |
| K101679 | ARTHREX PUSHLOCK ANCHORS | Arthrex, Inc. | 2010 |
Trace the full predicate network for K250544
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.