510(k) · Cleared
ClearedBelvedere™ Lateral Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 15, 2016 as substantially equivalent to K020244 (Synthes Spine, 2002) and 1 other predicate after a 263-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Jul 15, 2016
- Review
- 263 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K061789 (2006). 9 ancestors in all, the oldest K922543 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK061789 Lateral Plate SystemNuvasive, Inc. · 2006
- 2 generations backK091071 Nuvasive Lateral Plate SystemNuvasive, Inc. · 2009
- 1 generation backK133194 Diamond Rattlesnake SystemEminent Spine · 2014
- This deviceK153097 Belvedere™ Lateral Plating SystemNeurostructures, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061789 | Lateral Plate System | Nuvasive, Inc. | 2006 | — |
| −2 | K091071 | Nuvasive Lateral Plate System | Nuvasive, Inc. | 2009 | — |
| −1 | K133194 | Diamond Rattlesnake System | Eminent Spine | 2014 | — |
| 0 (this device) | K153097 | Belvedere™ Lateral Plating System | Neurostructures, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP)Summary page 5…ufacture e Principles of operation Table 5-1 Predicate Devices K153097 - Page 2 of 2 S10k Trade or Proprietary or Model Name Manufacturer Type Number K020244 Thoracolumbar Spine Locking Plate (TSLP) Synthes Primary System K133194 Black/Red Dlamgnd Rattlesnake Lumbar Eminent Spine Addit… | 2002 |
| * | K133194 | Diamond Rattlesnake SystemSummary page 5…vices K153097 - Page 2 of 2 S10k Trade or Proprietary or Model Name Manufacturer Type Number K020244 Thoracolumbar Spine Locking Plate (TSLP) Synthes Primary System K133194 Black/Red Dlamgnd Rattlesnake Lumbar Eminent Spine Additional Plating System K143230 Palladian™ Lumbar Pedicle Screw System Neuro… | 2014 |
| † | K143230 | Palladian Lumbar Pedicle Screw System | 2015 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- 6 other devices also cite its predicate K020244.
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. 2016, 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 Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a 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/K153097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153097: Belvedere™ Lateral Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153097
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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