510(k) · Cleared
ClearedDakota ALIF Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 4, 2021 as substantially equivalent to K091044 (Spinal USA, 2009) and 2 other predicates after a 50-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Nov 4, 2021
- Review
- 50 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K922543 (1993). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 5 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 4 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- 3 generations backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- 2 generations backK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- 1 generation backK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
- This deviceK212937 Dakota ALIF Plate SystemPrecision Spine, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −5 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −4 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −3 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| −2 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| −1 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
| 0 (this device) | K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K091044 | Spinal Usa Anterior Lumbar Plate SystemSummary page 5…Trade or Proprietary or Manufacturer Product Predicate Model Name Code Type K091044 (Primary), Spinal USA Anterior Spinal USA KWQ Primary K070922 Lumbar Plate… | 2009 |
| * | K070922 | Modification to Spinal Usa VBR SystemSummary page 5…Model Name Code Type K091044 (Primary), Spinal USA Anterior Spinal USA KWQ Primary K070922 Lumbar Plate System (Precision Spine) K080429 PYRAMID® +4 Anterior Medtroni… | 2007 |
| * | K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate SystemSummary page 5…K091044 (Primary), Spinal USA Anterior Spinal USA KWQ Primary K070922 Lumbar Plate System (Precision Spine) K080429 PYRAMID® +4 Anterior Medtronic KWQ Additional Lumbar Pl… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 6 other devices also cite its predicate K091044.
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. 2021, 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 Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following…
Read the full statement (114 words)
The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212937: Dakota ALIF 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/K212937
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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