510(k) · Cleared
ClearedSapphire X3 Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 2, 2023 as substantially equivalent to K152455 (Amendia, Inc., 2015) and 1 other predicate after a 62-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Aug 2, 2023
- Review
- 62 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971730 (1997). 36 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 6 generations backK013439 Anterior Cervical Plate SystemScien'Tx USA, Inc. · 2002
- 5 generations backK042317 Cervical PlateScient'X · 2004
- 4 generations backK070681 Next Generation Anterior Cervical Plating SystemAlphatec Spine, Inc. · 2007 · Recalled
- 3 generations backK112533 Zavation Cervical Plate SystemZavation, LLC · 2011
- 2 generations backK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- 1 generation backK152455 Amendia Cervical Plate SystemAmendia, Inc. · 2015
- This deviceK231593 Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −6 | K013439 | Anterior Cervical Plate System | Scien'Tx USA, Inc. | 2002 | — |
| −5 | K042317 | Cervical Plate | Scient'X | 2004 | — |
| −4 | K070681 | Next Generation Anterior Cervical Plating System | Alphatec Spine, Inc. | 2007 | 1 |
| −3 | K112533 | Zavation Cervical Plate System | Zavation, LLC | 2011 | — |
| −2 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| −1 | K152455 | Amendia Cervical Plate System | Amendia, Inc. | 2015 | — |
| 0 (this device) | K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K152455 | Amendia Cervical Plate SystemSummary page 5…Tumor x Pseudoarthrosis x Failed previous fusion Predicate Devices Primary Predicate: Ceres Midline Spinal System (previously the Amendia Cervical Plate System) - K152455 Additional Predicate: Sapphire X Anterior Cervical Plate System - K201029 Substantial Equivalence The subject devices are substa… | 2015 |
| * | K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal SystemSummary page 5…Primary Predicate: Ceres Midline Spinal System (previously the Amendia Cervical Plate System) - K152455 Additional Predicate: Sapphire X Anterior Cervical Plate System - K201029 Substantial Equivalence The subject devices are substantially equivalent in indications for use, surgical technique, and general… | 2020 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 36 ancestors have a recall of any class.
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. 2023, 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 Sapphire X3 Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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
• Deformities or Curvatures (kyphosis, lordosis or scoliosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231593: Sapphire X3 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/K231593
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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