Class Class II
PYXIS 3D Titanium Cage System (K223868)
Description
PYXIS 3D Titanium Cage System by GS Medical Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223868
Clearance Date2023-04-26
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223868
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. PYXIS 3D Titanium Cage System (K223868) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titaniu... | Eit Emerging Implant Technologies GmbH | 2017 |
| K100516 | ANYPLUS PEEK CAGES | GS Medical Co., Ltd. | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024 |
Trace the full predicate network for K223868
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.