# K231715: MONDRIAN™ Anterior Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Jan 26, 2024 after 227 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 289 ancestors in all.
No later device cites it as a predicate yet.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213641: MONDRIAN ALIF Cage with Supplementary Fixation Plate, Ctl Medical Corporation (2022) Summary page 4.
- K173885: Genesys Spine Binary Lumbar Plate System, Genesys Spine (2018) Summary page 4.
- K131981: Cezanne II Interbody Fusion System, Accel Spine (2013) Summary page 4.

## Indications for use
The MONDRIAN Lumbar Plate System is indicated as additional support during fusion in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K231715
Methodology: https://510kreport.com/methodology