510(k) · Cleared
ClearedModification to Spinal Usa VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 19, 2007 as substantially equivalent to K022791 (Synthes (Usa), 2002) and 4 other predicates after a 170-day review. Its family tree reaches back 4 generations to 1993. 161 later devices descend from it.
- Decided
- Sep 19, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K922543 (1993). 10 ancestors in all. 161 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 3 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- 1 generation backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- This deviceK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- Descendant · cites it directly · 159 of its ownK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
- Descendant · 2 generations on · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 113 of its ownK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
- Descendant · 3 generations on · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 4 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009 · cites it directly159descendants
- K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · 2 generations on113descendants
- K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010 · 2 generations on113descendants
- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · 3 generations on110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 4 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −3 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −1 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| 0 (this device) | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| +1 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
| +2 | K121791 | Zou Anterior Lumbar Plate System | Corelink, LLC | 2012 | — |
| +2 | K101255 | Alphatec Spine Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2010 | — |
| +3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +4 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 12 | 0 |
| 2021 | 11 | 0 |
| 2022 | 17 | 0 |
| 2023 | 26 | 0 |
| 2024 | 26 | 0 |
| 2025 | 24 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…888.3060 Classification: Class II Product Code: KWQ Predicate Devices: Synthes Anterior Tension Band System (K022791) Aegis Anterior Lumbar Plate System (K052546) Pyramid Anter… | 2002 |
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 1…KWQ Predicate Devices: Synthes Anterior Tension Band System (K022791) Aegis Anterior Lumbar Plate System (K052546) Pyramid Anterior Plate Fixation System (KO 13665) UnityLX… | 2006 |
| * | K013665 | Pyramid Anterior Plate Fixation System | 2002 |
| * | K061229 | Unity LX Anterolateral Lumbar Plate Fixation SystemSummary page 1…52546) Pyramid Anterior Plate Fixation System (KO 13665) UnityLX Anterolateral Lumbar Plate System (K061229) Trinica Anterior Lumbar Plate System (K061353) INTENDED USE: The Spinal USA Anterior Lumba… | 2006 |
| * | K061353 | Trinica Anterior Lumbar Plate SystemSummary page 1…KO 13665) UnityLX Anterolateral Lumbar Plate System (K061229) Trinica Anterior Lumbar Plate System (K061353) INTENDED USE: The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation d… | 2006 |
What descends from it? (161)
See all 1613 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 14 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K091044 (Spinal USA, 2009) has gone furthest, with 159 descendants of its own.
- 14 other devices also cite its predicate K022791.
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. 2007, 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 Spinal USA Anterior Lumbar Plate System is intended 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 Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (LI -SI)…
Read the full statement (119 words)
The Spinal USA Anterior Lumbar Plate System is intended 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 Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (LI -SI) fixation for the following indications: degenerative disc disease (DDD), defined as neck 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), tunmor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070922: Modification to Spinal Usa VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070922
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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