Class Class II
TheRay Collared and Collarless Femoral Stem (K241875)
Description
TheRay Collared and Collarless Femoral Stem by Nextstep Arthropedix, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241875
Clearance Date2024-09-13
Clearance TypeTraditional
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241875
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. TheRay Collared and Collarless Femoral Stem (K241875) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191927 | Hinged Laminoplasty System | Life Spine, Inc. | 2019 |
| K191936 | iNSitu Total Hip System | Thecken Companies, LLC | 2019 |
| K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 |
Trace the full predicate network for K241875
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.