# K191796: Neo Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Neo Medical SA
- Decided: Dec 13, 2019 after 163 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: 20 generations back to K841189 (1984). 171 ancestors in all.
No later device cites it as a predicate yet.
1 of 172 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181048: Neo Cage System TM, Neo Medical SA (2019) Summary page 4.
- K152304: Tritanium PL Cage, Stryker (2015) Summary page 4.
- K153621: Juliet® Ti, Spineart (2016) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K082342: Modification to Capstone Spinal System, Medtronic Sofamor Danek (2008) Summary page 4.
- K153783: SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF, Spinevision S.A. (2016) Summary page 4.

## Indications for use
NEO Cage System™ is an intervertebral body fusion device intended to be used with autogenous bone graft to facilitate interbody fusion and to be used with supplemental spinal fixation systems that have been cleared for the use in the lumbosacral spine. The cage is to be implanted in open surgery via a posterior or transforaminal approach. The indication for use is Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K191796
Methodology: https://510kreport.com/methodology