510(k) · Cleared
ClearedAurora® Anterior Lumbar Plate Sytstem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prism Surgical Design Pty, Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 5, 2020 as substantially equivalent to K052546 (Depuy Spine, Inc., 2006) and 1 other predicate after a 105-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Aug 5, 2020
- Review
- 105 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922543 (1993). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 4 generations backK014267 Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK022070 Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK071416 Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007
- 1 generation backK080429 Modificaton to: Pyramid +4 Anterior Lumbar Plate SystemMedtronic Sofamor Danek USA, Inc. · 2008
- This deviceK201079 Aurora® Anterior Lumbar Plate SytstemPrism Surgical Design Pty, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −4 | K014267 | Butterfly Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K022070 | Xantus Anterior Lateral Supplemental Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K071416 | Pyramid +4 Anterior Lumbar Spine Plate System | Medtronic Sofamor Danek USA, Inc. | 2007 | — |
| −1 | K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| 0 (this device) | K201079 | Aurora® Anterior Lumbar Plate Sytstem | Prism Surgical Design Pty, Ltd. | 2020 | — |
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 | 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 |
|---|---|---|---|
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 5…Trade or Proprietary or Manufacturer Predicate Model Name Type K052546 AEGIS Anterior Lumbar DePuy Spine, Inc. Primary Plate System… | 2006 |
| * | K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate SystemSummary page 5…Type K052546 AEGIS Anterior Lumbar DePuy Spine, Inc. Primary Plate System K080429 Pyramid® Anterior Lumbar Medtronic Sofamor Additional Plate Syste… | 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 27 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 10 ancestors has a recall.
- 8 other devices also cite its predicate K052546.
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. 2020, 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 Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following; x degenerative disc disease (defined…
Read the full statement (139 words)
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following;
x degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
x spondylolisthesis
x trauma (i.e., fracture or dislocation)
x spinal stenosis
x deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
x tumor
x pseudoarthrosis
x failed previous fusion
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201079: Aurora® Anterior Lumbar Plate Sytstem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201079
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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