510(k) · Cleared
ClearedRaven Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 3, 2019 as substantially equivalent to K150449 (Stryker Corp., 2015) and 4 other predicates after a 45-day review. Its family tree reaches back 9 generations to 1999. 2 later devices descend from it.
- Decided
- Jan 3, 2019
- Review
- 45 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K990745 (1999). 51 ancestors in all, the oldest K922543 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK150449 LITe Plate SystemStryker Corp. · 2015
- This deviceK183214 Raven Lumbar Plate SystemChoicespine, LP · 2019
- Descendant · cites it directly · 0 of its ownK260015 ANTERIS Thoracolumbar Plate SystemSpineCraft · 2026
- Descendant · cites it directly · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK150449 LITe Plate SystemStryker Corp. · 2015
- This deviceK183214 Raven Lumbar Plate SystemChoicespine, LP · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −1 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| 0 (this device) | K183214 | Raven Lumbar Plate System | Choicespine, LP | 2019 | — |
| +1 | K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026 | — |
| +1 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2012 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K150449 | LITe Plate SystemSummary page 5…te System was shown to be substantially equivalent to its predicate devices. Predicate Device: Primary predicate: Stryker Spine LITe® Plate System (K150449), Additional Predicate: Corelink, LLC Zou Anterior Lumbar Plate System (K121791), and Med… | 2015 |
| * | K121791 | Zou Anterior Lumbar Plate SystemSummary page 5…mary predicate: Stryker Spine LITe® Plate System (K150449), Additional Predicate: Corelink, LLC Zou Anterior Lumbar Plate System (K121791), and Meditech Spine, LLC CureTM Lumbar Plate System (K171538), Altiva Corporation, Altes Anterior Buttress P… | 2012 |
| * | K171538 | Cure™ Lumbar Plate SystemSummary page 5…Additional Predicate: Corelink, LLC Zou Anterior Lumbar Plate System (K121791), and Meditech Spine, LLC CureTM Lumbar Plate System (K171538), Altiva Corporation, Altes Anterior Buttress Plating System (K061482), Globus, Plymouth… | 2017 |
| * | K061482 | Altes Buttress Plating SystemSummary page 5…(K121791), and Meditech Spine, LLC CureTM Lumbar Plate System (K171538), Altiva Corporation, Altes Anterior Buttress Plating System (K061482), Globus, Plymouth Thoracolumbar Plate System (K120092). | 2006 |
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 5…tem (K171538), Altiva Corporation, Altes Anterior Buttress Plating System (K061482), Globus, Plymouth Thoracolumbar Plate System (K120092). | 2012 |
What descends from it? (2)
2 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 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 3 of the 51 ancestors have a recall of any class.
- Of its descendants, K260015 (SpineCraft, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K150449.
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. 2019, 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 Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature…
Read the full statement (200 words)
The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• 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;
• Spinal stenosis;
• Tumors;
• Trauma (i.e. Fractures or Dislocation);
• Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
• Failed Previous Fusion
The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183214: Raven 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/K183214
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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