# K062836: Citadel Anterior Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 19, 2006 after 90 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: 6 generations back to K990745 (1999). 19 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K062407: Gateway Thoracolumbar Plate System, Globus Medical, Inc. (2006) Summary page 1.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.

## Most influential descendants
- K142699: LITe Plate System (2014), 46 descendants of its own
- K150449: LITe Plate System (2015), 24 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K192481: AccelFix Lumbar Plate System (2020), 13 descendants of its own
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own

## Indications for use
The CITADEL™ Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach 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.

Source page: https://510kreport.com/device/K062836
Methodology: https://510kreport.com/methodology