# K192248: Cortina™ [MAX] Lumbar Cage System

- Pathway: 510(k) (Special)
- Applicant: Neurostructures, Inc.
- Decided: Nov 25, 2019 after 98 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). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 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.
- K180431: Cortina [MAX] Lumbar Cage System, Neurostructures, Inc. (2018) Summary page 4.
- K172064: Ti-Diagon Oblique TLIF, Camber Spine Technologies (2017) Summary page 5.
- K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF), Huvexel Co., Ltd. (2017) Summary page 5.

## 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 to S1 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 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/K192248
Methodology: https://510kreport.com/methodology