Class Class II
RibFix Titan™ Fixation System (K241282)
Description
RibFix Titan™ Fixation System by Riverpoint Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241282
Clearance Date2024-08-19
Clearance TypeTraditional
Product CodeHRS
Regulation Number888.3030
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241282
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. RibFix Titan™ Fixation System (K241282) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2022 |
| K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | 2021 |
| K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026 |
Trace the full predicate network for K241282
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.