Class Class II
TiLink-P SI Joint Fusion System (K243835)
Description
TiLink-P SI Joint Fusion System by SurGenTec, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243835
Clearance Date2024-12-27
Clearance TypeSpecial
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243835
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. TiLink-P SI Joint Fusion System (K243835) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242141 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024 |
| K231831 | TiLink-L Joint Fusion System | Surgentec | 2023 |
| K230446 | TiLink-L SI Joint Fusion System | SurGenTec, LLC | 2023 |
| K110472 | SI-FIX SACROILIAC JOINT FUSION SYSTEM | Medtronic Sofamor Danek | 2012 |
Trace the full predicate network for K243835
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.