510(k) · Cleared
ClearedHyper-C 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 Jul 28, 2015 as substantially equivalent to K142237 (Stryker Corporation, 2015) after a 127-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Jul 28, 2015
- Review
- 127 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000536 (2000). 6 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK000536 Synthes Anterior CSLP SystemSynthes Spine · 2000 · Recalled
- 3 generations backK062310 Reflex Hybrid Acp SystemStryker Spine · 2006 · Recalled
- 2 generations backK083562 Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp. · 2009
- 1 generation backK142237 Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation · 2015
- This deviceK150759 Hyper-C Anterior Cervical Plate SystemDegen Medical · 2015
- Descendant · cites it directly · 1 of its ownK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
- Descendant · cites it directly · 0 of its ownK181549 Curiteva Midline Anterior Cervical Plate System (or Curiteva…Curiteva, LLC · 2018
- Descendant · cites it directly · 0 of its ownK181562 Curiteva Anterior Cervical Plate SystemCuriteva, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019 · cites it directly1descendant
- K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022 · cites it directly0descendants
- K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC · 2018 · cites it directly0descendants
- K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000536 | Synthes Anterior CSLP System | Synthes Spine | 2000 | 1 |
| −3 | K062310 | Reflex Hybrid Acp System | Stryker Spine | 2006 | 2 |
| −2 | K083562 | Stryker Spine Nulock Anterior Cervical Plating System | Stryker Corp. | 2009 | — |
| −1 | K142237 | Aviator Anterior Cervical Plate (ACP) System | Stryker Corporation | 2015 | — |
| 0 (this device) | K150759 | Hyper-C Anterior Cervical Plate System | Degen Medical | 2015 | — |
| +1 | K191786 | Cyclops™ Anterior Cervical Plate System | Degen Medical, Inc. | 2019 | — |
| +1 | K213901 | Cyclops™ Anterior Cervical Plate System | Degen Medical | 2022 | — |
| +1 | K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical… | Curiteva, LLC | 2018 | — |
| +1 | K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K142237 | Aviator Anterior Cervical Plate (ACP) SystemSummary page 4…inal intervertebral body fixation orthosis Code –Classification KWQ 21 CFR 888.3060 : Class II Primary Predicate K142237 Stryker Aviator Anterior Cervical Plating System Reference Devices K083562 Stryker Aviator Anterior Cervical Plating… | 2015 |
| † | K083562 | Stryker Spine Nulock Anterior Cervical Plating System | 2009 |
| † | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | 1997 |
| † | K030866 | Synthes Anterior CSLP System | 2003 |
| † | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | 2003 |
| † | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | 1993 |
| † | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate System | 1995 |
| † | K052292 | Spider Cervical Plating (SCP) System | 2005 |
| † | K013887 | Bacfix Spinal Fixation System | 2002 |
| † | K121658 | Orthofix Acp (Anterior Cervical Plate System) | 2012 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K191786 (Degen Medical, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K142237.
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. 2015, 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 Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C 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 Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C 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 spine following total or partial cervical vertebrectomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150759: Hyper-C 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/K150759
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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