510(k) · Cleared
ClearedVertebron SCP Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertebron, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 26, 2004 as substantially equivalent to K022344 (Centerpulse Spine-Tech, Inc., 2002) and 2 other predicates after an 84-day review. Its family tree reaches back 5 generations to 1992. 12 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K922087 (1992). 21 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 3 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 2 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 1 generation backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- This deviceK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK081567 Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K043181Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004 · cites it directly11descendants
- K051815Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005 · cites it directly10descendants
- K062110Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006 · 2 generations on9descendants
- K081567Vertebron SSP Cervical Plating SystemVertebron, Inc. · 2008 · cites it directly6descendants
- K073530Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −4 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −3 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −2 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −1 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| 0 (this device) | K040003 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| +1 | K043181 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| +1 | K051815 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2005 | — |
| +2 | K062110 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2006 | — |
| +1 | K081567 | Vertebron SSP Cervical Plating System | Vertebron, Inc. | 2008 | — |
| +1 | K073530 | Accin Anterior Cervical Plate System | Accelerated Innovation, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (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 |
|---|---|---|---|
| * | K022344 | Trinica Select Anterior Cervical Plate SystemSummary page 1…Class II COMMON NAME Anterior Cervical Plate PROPRIETARY NAME Vertebron SCPTM Cervical Plate System PREDICATE DEVICES Centerpulse Spine-Tech K022344 Theken Surgical K0 10466 Blackstone Medical K030595 DEVICE The device consi… | 2002 |
| * | K010466 | Tether AcfsSummary page 1…nterior Cervical Plate PROPRIETARY NAME Vertebron SCPTM Cervical Plate System PREDICATE DEVICES Centerpulse Spine-Tech K022344 Theken Surgical K0 10466 Blackstone Medical K030595 DEVICE The device consists of a system of implantable metal plates D… | 2001 |
| * | K030595 | Blackstone Fusion Anterior Cervical Plating SystemSummary page 1…ebron SCPTM Cervical Plate System PREDICATE DEVICES Centerpulse Spine-Tech K022344 Theken Surgical K0 10466 Blackstone Medical K030595 DEVICE The device consists of a system of implantable metal plates DESCRIPTION and screws intended the purp… | 2003 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043181 | Modification to Vertebron SCP Cervical Plate System | 2004 | 11 |
| K051815 | Modification to Vertebron SCP Cervical Plate System | 2005 | 10 |
| K081567 | Vertebron SSP Cervical Plating System | 2008 | 6 |
| K073530 | Accin Anterior Cervical Plate System | 2008 | 3 |
| K091396 | Cardo Medical Anterior Cervical Plate System | 2009 | 2 |
| K163061 | Altus Spine Cervical Plate System | 2017 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K043181 (Vertebron, Inc., 2004) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K022344.
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 Vertebron SCPTM Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040003: Vertebron SCP 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/K040003
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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