510(k) Report

510(k) · Cleared

Cleared

Cyclops™ Anterior Cervical Plate System

K191786510(k) TraditionalCleared Aug 30, 201958-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Degen Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 30, 2019 as substantially equivalent to K150759 (Degen Medical, 2015) and 10 other predicates after a 58-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it.

Decided
Aug 30, 2019
Review
58 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
11

Its longest line of descent runs back 9 generations to K922087 (1992). 57 ancestors in all, the oldest K831246 (1983). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 2 other ancestors2014: 1 other ancestor2008: 2 other ancestors2005: 2 other ancestors2003: 4 other ancestors2001: 1 other ancestor1997: 4 other ancestors1995: 2 other ancestors1993: 1 other ancestor2010: 1 other ancestor2007: 3 other ancestors2006: 3 other ancestors2004: 6 other ancestors2009: 2 other ancestors2002: 1 other ancestor2000: 4 other ancestors1998: 4 other ancestors1999: 3 other ancestors1992: 1 other ancestor1983: 1 other ancestor2022: 1 descendant clearedK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K043066 · Pioneer Anterior Cervical Plate System · Pioneer Surgical Technology · 2005K053053 · Pacp System · Pioneer Surgical Technology · 2005K072703 · Pioneer Slimfuse Anterior Cervical Plating System · Pioneer Surgical Technology · 2008K100708 · Pioneer Anterior Cervical Plate Model 24-Series · Pioneer Surgical Technology · 2010K111528 · Pioneer Aspect Anterior Cervical Plate Model 24-Series · Pioneer Surgical Technology, Inc. · 2011K121658 · Orthofix Acp (Anterior Cervical Plate System) · Orthofix, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 9 other ancestors3 generations back: 9 other ancestors4 generations back: 5 other ancestors5 generations back: 8 other ancestors6 generations back: 7 other ancestors 1 generation forward: 1 descendant K121658 · Orthofix Acp (Anterior Cervical Plate System) · Orthofix, Inc. · 2012K111528 · Pioneer Aspect Anterior Cervical Plate Model 24-Series · Pioneer Surgical Technology, Inc. · 2011K100708 · Pioneer Anterior Cervical Plate Model 24-Series · Pioneer Surgical Technology · 2010K072703 · Pioneer Slimfuse Anterior Cervical Plating System · Pioneer Surgical Technology · 2008K053053 · Pacp System · Pioneer Surgical Technology · 2005K043066 · Pioneer Anterior Cervical Plate System · Pioneer Surgical Technology · 2005K000486 · Abc Cervical Plating System · Aesculap, Inc. · 2000K990005 · Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System · Spinal Concepts, Inc. · 1999 · recalledK922087 · Anterior Cervical Plate System · Sofamor Danek Mfg., Inc. · 1992−50
  1. Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 5 generations between
  3. 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
  4. 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
  5. 1 generation backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
  6. This deviceK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
  7. Descendant · cites it directly · 0 of its ownK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
Show all 9 generations
  1. Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
  2. 8 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
  3. 7 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
  4. 6 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
  5. 5 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
  6. 4 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
  7. 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
  8. 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
  9. 1 generation backK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
  10. This deviceK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K922087Anterior Cervical Plate SystemSofamor Danek Mfg., Inc.1992—
−8K990005Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc.19991
−7K000486Abc Cervical Plating SystemAesculap, Inc.2000—
−6K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology2005—
−5K053053Pacp SystemPioneer Surgical Technology2005—
−4K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology2008—
−3K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology2010—
−2K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.2011—
−1K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.2012—
0 (this device)K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.2019—
+1K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199310
199520
199740
199840
199930
200040
200110
200210
200340
200460
200520
200630
200730
200820
200920
201010
201410
201520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K191786, 1992–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K150759Hyper-C Anterior Cervical Plate System
Summary page 4
…inal Intervertebral Body Fixation Orthosis KWQ Code –Classification 21 CFR 888.3060: Class II Primary Predicate K150759 Hyper-C Anterior Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate Sys…
Degen Medical2015—
*K971883Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System
Summary page 4
…Code –Classification 21 CFR 888.3060: Class II Primary Predicate K150759 Hyper-C Anterior Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes…
Synthes (Usa)19971
*K030866Synthes Anterior CSLP System
Summary page 4
…K150759 Hyper-C Anterior Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K…
Synthes (Usa)2003—
*K031276Synthes Anterior Cervical Locking Plate (Aclp) System
Summary page 4
…59 Hyper-C Anterior Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K…
Synthes (Usa)2003—
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 4
…C Anterior Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Or…
Synthes (Usa)1993—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 4
…r Cervical Plate System K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Ha…
Synthes (Usa)1995—
*K052292Spider Cervical Plating (SCP) System
Summary page 4
…K971883 Synthes Small Stature Anterior Cervical Locking Plate System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System…
X-Spine Systems, Inc.2005—
*K013877Codman Slim-Loc System
Summary page 4
…e System K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System K080646, K133518 Biomet Maxan Anterior Cervica…
Codman & Shurtleff, Inc.2001—
*K121658Orthofix Acp (Anterior Cervical Plate System)
Summary page 4
…K030866, K031276, K926453, K945700 Synthes CSLP Additional Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System K080646, K133518 Biomet Maxan Anterior Cervical Plate S…
Orthofix, Inc.2012—
*K080646C-Tek Maxan Anterior Cervical Plate System
Summary page 4
…al Predicates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System K080646, K133518 Biomet Maxan Anterior Cervical Plate System The DeGen Medical CyclopsTM Anterior Cervical Plate…
Biomet Spine20082
*K133518Maxan Anterior Cervical Plate System
Summary page 4
…ates K052292 X-Spine Spider Cervical Plate K013877, K121658 Orthofix Hallmark Anterior Cervical Plate System K080646, K133518 Biomet Maxan Anterior Cervical Plate System The DeGen Medical CyclopsTM Anterior Cervical Plate Systems…
Biomet Spine (Aka Ebi, LLC)20141

Also cleared against K150759: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220

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 27 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
  • 8 of the 57 ancestors have a recall of any class.
  • Of its descendants, K213901 (Degen Medical, 2022) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K150759.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

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 (134 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 as stated in the FDA summary.

Also cleared against K150759

3 other devices cite the same predicate.

  • K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
  • K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)Curiteva, LLC · 2018
  • K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC · 2018

More from Degen Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc. · 2024

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K191786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191786: Cyclops™ 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/K191786

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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