510(k) · Cleared
ClearedC3 Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Vision, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 26, 2001 as substantially equivalent to K000742 (Synthes Spine, 2000) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Nov 26, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926453 (1993). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 1 generation backK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
- This deviceK012881 C3 Anterior Cervical Plate SystemSpine Vision, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK112809 Blue Mountain Cervical PlateQualgenix, LLC · 2012
- Descendant · 2 generations on · 1 of its ownK150036 Blue Mountain Cervical Plate SystemSpineway · 2015
- Descendant · 3 generations on · 0 of its ownK163602 Kepler I Cervical Plate SystemOrbbo Surgical, LLC · 2017
- Descendant · cites it directly · 0 of its ownK073500 Active Anterior Cervical Plate SystemSanacor · 2008
Most influential descendants
Showing 4 of 4 · See all- K112809Blue Mountain Cervical PlateQualgenix, LLC · 2012 · cites it directly2descendants
- K150036Blue Mountain Cervical Plate SystemSpineway · 2015 · 2 generations on1descendant
- K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC · 2017 · 3 generations on0descendants
- K073500Active Anterior Cervical Plate SystemSanacor · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −1 | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps) | Synthes (Usa) | 1997 | — |
| 0 (this device) | K012881 | C3 Anterior Cervical Plate System | Spine Vision, Inc. | 2001 | — |
| +1 | K112809 | Blue Mountain Cervical Plate | Qualgenix, LLC | 2012 | — |
| +2 | K150036 | Blue Mountain Cervical Plate System | Spineway | 2015 | — |
| +3 | K163602 | Kepler I Cervical Plate System | Orbbo Surgical, LLC | 2017 | — |
| +1 | K073500 | Active Anterior Cervical Plate System | Sanacor | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K000742 | Synthes Anterior CSLP SystemSummary page 1…ed for stabilization of the _ spine from C2 to C7 during the time interval required for arthrodesis. Substantial Equivalence: Synthes (USA) Synthes Spine Anterior CSLP (K000742) Synthes (USA) Titanium Locking Plate System (TILPS) (K970048) é‘*" ‘“"'-‘l:.% Public Health Service Pli? é DE… | 2000 |
| * | K970048 | Synthes (Usa)Titanium Locking Plate System (Tilps)Summary page 1…me interval required for arthrodesis. Substantial Equivalence: Synthes (USA) Synthes Spine Anterior CSLP (K000742) Synthes (USA) Titanium Locking Plate System (TILPS) (K970048) é‘*" ‘“"'-‘l:.% Public Health Service Pli? é DEPARTMENT OF HEALTH & HUMAN SERVICES ", e Food and Drug Adminis… | 1997 |
What descends from it? (4)
2 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 8 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112809 (Qualgenix, LLC, 2012) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K000742.
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 C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion. The C*™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back…
Read the full statement (111 words)
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C*™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C®™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
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/K012881 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012881: C3 Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012881
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026