# K223868: PYXIS 3D Titanium Cage System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Apr 26, 2023 after 124 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 18 generations back to K841189 (1984). 174 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 177 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.
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF, Eit Emerging Implant Technologies GmbH (2018) Summary page 5.
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 5.

## Most influential descendants
- K241738: PYXIS 3D Titanium Cervical Cage system (2024), 1 descendant of its own
- K243915: FIX-C 3D Ti ACIF System (2025), 0 descendants of its own

## Indications for use
The PYXIS 3D Titanium Cage System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K223868
Methodology: https://510kreport.com/methodology