Class Class II
DYNAMIS™ Implant System (K251075)
Description
DYNAMIS™ Implant System by Promethean Restorative, LLC, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251075
Clearance Date2025-04-25
Clearance TypeSpecial
Product CodeOUR
Regulation Number888.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251075
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. DYNAMIS™ Implant System (K251075) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243565 | DYNAMIS SI Screw System | Promethean Restorative, LLC | 2025 |
| K193211 | Nano FortiFix® System | Nanovis Spine, LLC | 2020 |
Trace the full predicate network for K251075
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.