Class Class II
Response Ortho Metaphyseal Hinge Fixator System (K241769)
Description
Response Ortho Metaphyseal Hinge Fixator System by Response Ortho Solutions, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241769
Clearance Date2024-09-18
Clearance TypeTraditional
Product CodeKTT
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241769
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. Response Ortho Metaphyseal Hinge Fixator System (K241769) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator,... | Smith & Nephew | 2020 |
Trace the full predicate network for K241769
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.