# K192863: MONDRIAN Lumbar Interbody Fusion Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Aug 26, 2020 after 324 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: 21 generations back to K841189 (1984). 245 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121567: Oracle Lumbar Intervertebral Body Fusion Cage System, Accel Spine (2012) Summary page 5.
- K131981: Cezanne II Interbody Fusion System, Accel Spine (2013) Summary page 5.
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 5.
- K091278: Valeo Spacer System, Amedica Corp. (2010) Summary page 5.
- K142347: Amedica Valeo II Interbody Fusion Device, Amedica Corp. (2014) Summary page 5.
- K143518: Valeo Spacer System and Valeo II Interbody Fusion Device System, Amedica Corp. (2015) Summary page 5.
- K121892: Phantom Plus Ceramic Cage System, Amedica Corp. (2012) Summary page 5.
- K161405: Valeo II Interbody Fusion Device System, Amedica Corp. (2016) Summary page 5.
- K143158: Xenco Medical Lumbar Interbody System, Xenco Medical, LLC (2015) Summary page 5.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.

## Most influential descendants
- K213641: MONDRIAN ALIF Cage with Supplementary Fixation Plate (2022), 1 descendant of its own
- K231715: MONDRIAN™ Anterior Lumbar Plate System (2024), 0 descendants of its own
- K220513: NITRO Interbody Fusion Cage System Family (2023), 0 descendants of its own

## Indications for use
The MONDRIAN™ Lumbar Interbody Fusion Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The system is to be used with supplemental fixation cleared for use in the lumbar spine. Hyperlordotic cage offerings (>20°) require the use of anterior fixation. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K192863
Methodology: https://510kreport.com/methodology