510(k) · Cleared
ClearedQuantum Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Orthopedics, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 13, 2006 after a 17-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Mar 13, 2006
- Review
- 17 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK060491 Quantum Anterior Cervical Plate SystemQuantum Orthopedics, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK101848 Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK201029 Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal…Spinal Elements, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK231593 Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc. · 2010 · cites it directly2descendants
- K201029Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSpinal Elements, Inc. · 2020 · 2 generations on1descendant
- K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060491 | Quantum Anterior Cervical Plate System | Quantum Orthopedics, Inc. | 2006 | — |
| +1 | K101848 | Sapphire Anterior Cervical Plate System | Spinal Elements, Inc. | 2010 | — |
| +2 | K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Spinal Elements, Inc. | 2020 | — |
| +3 | K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101848 | Sapphire Anterior Cervical Plate System | 2010 | 2 |
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?
- Of its descendants, K101848 (Spinal Elements, Inc., 2010) has gone furthest, with 2 descendants of its own.
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.
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 Quantum Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformaties or curvatures (kyphosis, lordosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060491: Quantum Anterior Cervical 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/K060491
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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