510(k) · Cleared
ClearedEnvision Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 5, 2002 after a 36-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Apr 5, 2002
- Review
- 36 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK020649 Envision Anterior Cervical Plate SystemOrtho Development Corp. · 2002
- Descendant · cites it directly · 1 of its ownK103505 Altum Anterior Cervical PlateSpinecraft, LLC · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK131521 Velox Anterior Cervical Plate SystemSpinecraft, LLC · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020649 | Envision Anterior Cervical Plate System | Ortho Development Corp. | 2002 | — |
| +1 | K103505 | Altum Anterior Cervical Plate | Spinecraft, LLC | 2011 | 1 |
| +1 | K131521 | Velox Anterior Cervical Plate System | Spinecraft, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | — | Synthes Anterior CSLP System Named without a submission number | |
| * | — | EBI Vuelock Anterior Cervical Plate System Named without a submission number | |
| * | — | Window Cervical Dynamic Plate System Named without a submission number |
What descends from it? (2)
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?
- Of its descendants, K103505 (Spinecraft, LLC, 2011) has gone furthest, with 1 descendant 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 Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Envision™ Anterior Cervical Plate System is intended for use under the following indications: Degenerative disc disease (defined…
Read the full statement (103 words)
The Envision™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The Envision™ Anterior Cervical Plate System is intended for use under the following indications:
Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spondylolisthesis
Trauma (i.e., fracture)
Tumor
Deformity (i.e., kyphosis, lordosis, and scoliosis)
Spinal stenosis
Pseudarthrosis
Failed previous fusion
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/K020649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020649: Envision 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/K020649
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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