# K232318: VICTORY™ Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Oct 31, 2023 after 89 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: 19 generations back to K853033 (1985). 136 ancestors in all.
No later device cites it as a predicate yet.
1 of 137 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062836: Citadel Anterior Lumbar Plate System, Globus Medical, Inc. (2006) Summary page 5.
- K050117: Modification to Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek (2005) Summary page 5.
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 5.
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System, Aegis Spine, Inc. (2022) Summary page 5.
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 5.

## Indications for use
The VICTORY™ Lumbar Plate System is indicated for use through an anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels, or through an anterior surgical approach below the bifurcation of the great vessels 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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery. The VICTORY™ Buttress Plate is intended to stabilize allograft or autograft at one level (L1-S1), aiding in spinal fusion and to provide temporary stabilization and augment development of a spinal fusion. The device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K232318
Methodology: https://510kreport.com/methodology
