510(k) · Cleared
ClearedOrion Anterior Cervical Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 17, 2004 as substantially equivalent to K973854 (Sofamor Danek USA,Inc., 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 1 of the 686 devices in its family, counting itself, has a Class I recall. 684 later devices descend from it.
- Decided
- Sep 17, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973854 (1998). 684 later devices descend from it, 3 citing it directly. 1 of the 686 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- This deviceK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 677 of its ownK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · 2 generations on · 669 of its ownK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- Descendant · 3 generations on · 637 of its ownK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 4 generations on · 397 of its ownK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- Descendant · 4 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
Showing 5 of 684 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 684 · See all- K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly677descendants
- K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006 · 2 generations on669descendants
- K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008 · 3 generations on637descendants
- K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010 · 4 generations on397descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 4 generations on389descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| 0 (this device) | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +2 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| +3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +4 | K094042 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek | 2010 | — |
| +4 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 13 | 0 |
| 2015 | 15 | 0 |
| 2016 | 24 | 0 |
| 2017 | 43 | 0 |
| 2018 | 33 | 0 |
| 2019 | 47 | 0 |
| 2020 | 61 | 0 |
| 2021 | 64 | 1 |
| 2022 | 64 | 0 |
| 2023 | 78 | 0 |
| 2024 | 73 | 0 |
| 2025 | 68 | 0 |
| 2026 | 65 | 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.
1 device in this family has a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | K973854 | Orion Anterior Cervical Plate SystemSummary page 1…Plate System screws were claimed to be substantially equivalent to the predicate ORION® Anterior Cervical Plate System screws cleared in K973854 (SE 3/16/98). A risk analysis and comparison data were provided in support of this notification.… | 1998 |
What descends from it? (684)
See all 6843 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or failed previous fusions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042235: Orion Anterior Cervical Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042235
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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