# K241738: PYXIS 3D Titanium Cervical Cage system

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Aug 20, 2024 after 64 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K841189 (1984). 179 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 181 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 5.
- K153517: AnyPlus® Cervical PEEK Cage System, GS Medical Co., Ltd. (2016) Summary page 5.
- K223868: PYXIS 3D Titanium Cage System, GS Medical Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K243915: FIX-C 3D Ti ACIF System (2025), 0 descendants of its own

## Indications for use
The GS Medical PYXIS 3D Titanium Cervical Cages indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K241738
Methodology: https://510kreport.com/methodology