# K180431: Cortina [MAX] Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Mar 22, 2018 after 34 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: 17 generations back to K841189 (1984). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171914: Cortina™ Lumbar Cage System, Neurostructures, Inc. (2017) Summary page 4.

## Most influential descendants
- K192248: Cortina™ [MAX] Lumbar Cage System (2019), 0 descendants of its own

## Indications for use
The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 lo S 1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confim1ed 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/K180431
Methodology: https://510kreport.com/methodology