510(k) · Cleared
ClearedVICTORY™ 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 Oct 31, 2023 as substantially equivalent to K062836 (Globus Medical, Inc., 2006) and 4 other predicates after an 89-day review. Its family tree reaches back 19 generations to 1985. 1 of the 137 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 31, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K853033 (1985). 136 ancestors in all. No later device cites it as a predicate yet. 1 of the 137 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations between
- 3 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 2 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 1 generation backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- This deviceK232318 VICTORY™ Lumbar Plate SystemGlobus Medical, Inc. · 2023
Show all 19 generations
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 10 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 9 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 8 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 7 generations backK142741 OASYS SystemStryker Corporation · 2015
- 6 generations backK150753 OASYS SystemStryker Corporation · 2015
- 5 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 4 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 3 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 2 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 1 generation backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- This deviceK232318 VICTORY™ Lumbar Plate SystemGlobus Medical, Inc. · 2023
Class I recalls in this family
- K093670 Modification to: Oasys System8 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −18 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −17 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −16 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −15 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −14 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −13 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −12 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −10 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −9 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −8 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −7 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −6 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −5 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −4 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −3 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| −2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| −1 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| 0 (this device) | K232318 | VICTORY™ Lumbar Plate System | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K062836 | Citadel Anterior Lumbar Plate SystemSummary page 5…hosis Product Code: KWQ Regulatory Class II, Panel Code 87 Primary Predicate: CITADEL™ Anterior Lumbar Plate System (K062836) Additional Predicates: Medtronic PYRAMID® Anterior Plate Fixation System (K050117)… | 2006 |
| * | K050117 | Modification to Pyramid Anterior Plate Fixation SystemSummary page 5…icate: CITADEL™ Anterior Lumbar Plate System (K062836) Additional Predicates: Medtronic PYRAMID® Anterior Plate Fixation System (K050117) Depuy AEGIS® Anterior Lumbar Plate System (K052546) AEGIS® Spinema Lumbar Plate System… | 2005 |
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 5…nal Predicates: Medtronic PYRAMID® Anterior Plate Fixation System (K050117) Depuy AEGIS® Anterior Lumbar Plate System (K052546) AEGIS® Spinema Lumbar Plate System (K221050) Stryker LITe® Plate System (K142699) Pur… | 2006 |
| * | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Summary page 5…n System (K050117) Depuy AEGIS® Anterior Lumbar Plate System (K052546) AEGIS® Spinema Lumbar Plate System (K221050) Stryker LITe® Plate System (K142699) Purpose: The purpose of this submission is to request clearance for t… | 2022 |
| * | K142699 | LITe Plate SystemSummary page 5…Depuy AEGIS® Anterior Lumbar Plate System (K052546) AEGIS® Spinema Lumbar Plate System (K221050) Stryker LITe® Plate System (K142699) Purpose: The purpose of this submission is to request clearance for the VICTORY™ Lumbar Plate System. Device Description: The… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 136 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K062836.
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. 2023, this device’s year, is highlighted.
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 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…
Read the full statement (132 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232318: VICTORY™ Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232318
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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