Class Class II
PYXIS 3D Titanium Cervical Cage system (K241738)
Description
PYXIS 3D Titanium Cervical Cage system by GS Medical Co., Ltd., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241738
Clearance Date2024-08-20
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241738
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 Cervical Cage system (K241738) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | 2023 |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titaniu... | Eit Emerging Implant Technologies GmbH | 2017 |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025 |
Trace the full predicate network for K241738
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.