Class Class II
VADER® Pedicle System, G21 Cement (K222789)
Description
VADER® Pedicle System, G21 Cement by Icotec AG, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222789
Clearance Date2023-01-09
Clearance TypeTraditional
Product CodePML
Regulation Number888.3027
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222789
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. VADER® Pedicle System, G21 Cement (K222789) cites 3 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System... | Icotec AG | 2019 |
| K151977 | icotec Pedicle System | Icotec AG | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024 |
| K232628 | VADER® Pedicle System | Icotec AG | 2024 |
| K230861 | VADER® Pedicle System Navigated Instruments | Icotec AG | 2023 |
Trace the full predicate network for K222789
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.