510(k) · Cleared
ClearedCitadel Anterior Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 19, 2006 as substantially equivalent to K061202 (Globus Medical, Inc., 2006) and 3 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1999. 50 later devices descend from it.
- Decided
- Dec 19, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K990745 (1999). 19 ancestors in all, the oldest K922543 (1993). 50 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 4 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 3 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 2 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 1 generation backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- This deviceK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- Descendant · cites it directly · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
- Descendant · 2 generations on · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K142699LITe Plate SystemStryker Corporation · 2014 · cites it directly46descendants
- K150449LITe Plate SystemStryker Corp. · 2015 · 2 generations on24descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
- K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −5 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −4 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −3 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −2 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −1 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| 0 (this device) | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| +1 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| +2 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020 | — |
| +3 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061202 | Revere Stabilization SystemSummary page 1…N: 21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class Il. Panel code 87. PREDICATE DEVICES: REVERE™ Stabilization System K061202 (SE July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (S… | 2006 |
| * | K062407 | Gateway Thoracolumbar Plate SystemSummary page 1…s Product Codes KWQ. Regulatory Class Il. Panel code 87. PREDICATE DEVICES: REVERE™ Stabilization System K061202 (SE July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (SE Jan 29,2002) Synthes Anterior Tension Band K022791 (SE Nov 13… | 2006 |
| * | K013665 | Pyramid Anterior Plate Fixation SystemSummary page 1…ATE DEVICES: REVERE™ Stabilization System K061202 (SE July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (SE Jan 29,2002) Synthes Anterior Tension Band K022791 (SE Nov 13, 2002) Product code KWQ. Regulatory Class Il. DEVICE DESCRIPT… | 2002 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (SE Jan 29,2002) Synthes Anterior Tension Band K022791 (SE Nov 13, 2002) Product code KWQ. Regulatory Class Il. DEVICE DESCRIPTION: The CITADEL™ Anterior Lumbar Plate System consist… | 2002 |
What descends from it? (50)
See all 503 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K142699 (Stryker Corporation, 2014) has gone furthest, with 46 descendants of its own.
- 29 other devices also cite its predicate K061202.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062836: Citadel Anterior Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062836
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026