510(k) · Cleared
ClearedOrion Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 16, 1998 after a 164-day review. The FDA summary names no predicate by number. 1 of the 832 devices in its family, counting itself, has a Class I recall. 831 later devices descend from it.
- Decided
- Mar 16, 1998
- Review
- 164 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
831 later devices descend from it, 7 citing it directly. 1 of the 832 devices in this family, counting this one, has a Class I recall.
- This deviceK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- Descendant · cites it directly · 694 of its ownK042499 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 684 of its ownK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 677 of its ownK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · 3 generations on · 669 of its ownK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- Descendant · 4 generations on · 637 of its ownK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
Showing 5 of 831 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 831 · See all- K042499Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004 · cites it directly694descendants
- K042235Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004 · cites it directly684descendants
- K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004 · 2 generations on677descendants
- K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006 · 3 generations on669descendants
- K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on637descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| +1 | K042499 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +3 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| +4 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 12 | 0 |
| 2011 | 12 | 0 |
| 2012 | 11 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 21 | 0 |
| 2016 | 28 | 0 |
| 2017 | 48 | 0 |
| 2018 | 42 | 0 |
| 2019 | 54 | 0 |
| 2020 | 75 | 0 |
| 2021 | 71 | 1 |
| 2022 | 71 | 0 |
| 2023 | 90 | 0 |
| 2024 | 81 | 0 |
| 2025 | 70 | 0 |
| 2026 | 72 | 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?
The FDA summary names no predicate by number.
What descends from it? (831)
See all 8317 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042499 | Orion Anterior Cervical Plating System | 2004 | 694 |
| K042235 | Orion Anterior Cervical Plating System | 2004 | 684 |
| K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | 1999 | 313 |
| K013439 | Anterior Cervical Plate System | 2002 | 64 |
| K051815 | Modification to Vertebron SCP Cervical Plate System | 2005 | 10 |
| K071990 | Valeo Cervical Plate System | 2007 | 1 |
| K051039 | Basis Spinal System | 2005 | 0 |
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042499 (Medtronic Sofamor Danek, 2004) has gone furthest, with 694 descendants 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 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)…
Read the full statement (103 words)
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.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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/K973854 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973854: Orion Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973854
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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