510(k) · Cleared
Recalled · Class II · 2015Genesys Spine Anterior Cervical Plate II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 8, 2014 as substantially equivalent to K111132 (Genesys Spine, 2011) and 3 other predicates after a 351-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 8, 2014
- Review
- 351 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 9 generations to K922087 (1992). 51 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 5 generations between
- 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- This deviceK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014
- Descendant · cites it directly · 0 of its ownK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
Show all 9 generations
- Root · 9 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 8 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 7 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 6 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 5 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 4 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 3 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 2 generations backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- 1 generation backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- This deviceK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014
Most influential descendants
Showing 1 of 1 · See all- K192076Binary® Anterior Cervical Plate SystemGenesys Spine · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −8 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −7 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −6 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −5 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −4 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −3 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −2 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| −1 | K130427 | Pioneer Aspect Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2013 | — |
| 0 (this device) | K133245 | Genesys Spine Anterior Cervical Plate II System | Genesys Spine | 2014 | — |
| +1 | K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (4)
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 |
|---|---|---|---|
| * | K111132 | Genesys Spine Anterior Cervical Plate SystemSummary page 4…edic and Rehabilitation Devices Panel Legally Marketed Genesys Spine Anterior Cervical Plate System (Primary (unmodified) device: Predicate K111132), Synthes Anterior CSLP System (K000536 / K945700), Pioneer Aspect Anterior Cervical… | 2011 |
| * | K000536 | Synthes Anterior CSLP SystemSummary page 4…nesys Spine Anterior Cervical Plate System (Primary (unmodified) device: Predicate K111132), Synthes Anterior CSLP System (K000536 / K945700), Pioneer Aspect Anterior Cervical Plate System (K1… | 2000 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 4…e Anterior Cervical Plate System (Primary (unmodified) device: Predicate K111132), Synthes Anterior CSLP System (K000536 / K945700), Pioneer Aspect Anterior Cervical Plate System (K130427) D… | 1995 |
| * | K130427 | Pioneer Aspect Anterior Cervical Plate SystemSummary page 4…(K000536 / K945700), Pioneer Aspect Anterior Cervical Plate System (K130427) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Genesys Spine Anterior Cervical Plate II System will be offer… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192076 | Binary® Anterior Cervical Plate System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2015 | Class II | Z-0040-2018 | Component design/selection | Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 51 ancestors have a recall of any class.
- Of its descendants, K192076 (Genesys Spine, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111132.
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. 2014, 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 Genesys Spine Anterior Cervical Plate II System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with…
Read the full statement (107 words)
The Genesys Spine Anterior Cervical Plate II System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133245: Genesys Spine Anterior Cervical Plate II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133245
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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