510(k) · Cleared
ClearedCyclops™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degen Medical · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 7, 2022 as substantially equivalent to K191786 (Degen Medical, Inc., 2019) and 1 other predicate after a 24-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jan 7, 2022
- Review
- 24 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K922087 (1992). 58 ancestors in all, the oldest K831246 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations between
- 3 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 2 generations backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
- 1 generation backK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
- This deviceK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
Show all 10 generations
- Root · 10 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 9 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 8 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 7 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 6 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 5 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 4 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 3 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 2 generations backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
- 1 generation backK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
- This deviceK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −9 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −8 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −7 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −6 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −5 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −4 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −3 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| −2 | K121658 | Orthofix Acp (Anterior Cervical Plate System) | Orthofix, Inc. | 2012 | — |
| −1 | K191786 | Cyclops™ Anterior Cervical Plate System | Degen Medical, Inc. | 2019 | — |
| 0 (this device) | K213901 | Cyclops™ Anterior Cervical Plate System | Degen Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K191786 | Cyclops™ Anterior Cervical Plate SystemSummary page 4…System Common Name Spinal intervertebral body fixation orthosis Product Code KWQ Classification 21 CFR 888.3060, Class II Primary Predicate K191786 CyclopsTM Anterior Cervical Plate System Additional Predicate K150759 DeGen Medical Hyper-C Anterior Cervical Plate System Devi… | 2019 |
| * | K150759 | Hyper-C Anterior Cervical Plate SystemSummary page 4…is Product Code KWQ Classification 21 CFR 888.3060, Class II Primary Predicate K191786 CyclopsTM Anterior Cervical Plate System Additional Predicate K150759 DeGen Medical Hyper-C Anterior Cervical Plate System Device Description The DeGen Medical CyclopsTM Anterior Cervical Plate Sy… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 58 ancestors have a recall of any class.
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. 2022, this device’s year, is highlighted.
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 DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications…
Read the full statement (126 words)
The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal Stenosis
Trauma (i.e. fracture or dislocation)
Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
Spinal Tumors
Pseudoarthrosis or failed previous fusion
Spondylolisthesis
Decompression of the spinal following total or partial cervical vertebrectomy
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/K213901 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213901: Cyclops™ Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213901
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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