510(k) · Cleared
Recalled · Class II · 2013Genesys Spine Anterior Cervical Plate 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 Dec 9, 2011 as substantially equivalent to K000536 (Synthes Spine, 2000) and 3 other predicates after a 231-day review. Its family tree reaches back 6 generations to 1998. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 9, 2011
- Review
- 231 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K973854 (1998). 22 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- 5 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- 4 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- 3 generations backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- 2 generations backK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
- 1 generation backK103137 Venus Anterior Cervical PlateVerticor, Ltd. · 2011
- This deviceK111132 Genesys Spine Anterior Cervical Plate SystemGenesys Spine · 2011
- Descendant · cites it directly · 1 of its ownK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK131512 Katia SystemShanghai Sanyou Medical Co, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
- Descendant · 2 generations on · 0 of its ownK163366 Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · cites it directly1descendant
- K131512Katia SystemShanghai Sanyou Medical Co, Ltd. · 2013 · cites it directly1descendant
- K192076Binary® Anterior Cervical Plate SystemGenesys Spine · 2019 · 2 generations on0descendants
- K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| −5 | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −3 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | 2010 | 2 |
| −1 | K103137 | Venus Anterior Cervical Plate | Verticor, Ltd. | 2011 | — |
| 0 (this device) | K111132 | Genesys Spine Anterior Cervical Plate System | Genesys Spine | 2011 | — |
| +1 | K133245 | Genesys Spine Anterior Cervical Plate II System | Genesys Spine | 2014 | 1 |
| +1 | K131512 | Katia System | Shanghai Sanyou Medical Co, Ltd. | 2013 | — |
| +2 | K192076 | Binary® Anterior Cervical Plate System | Genesys Spine | 2019 | — |
| +2 | K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…ent to the Synthes Anterior CS[P System [Synthes Spine, K<000536 1 K<9457001, Venus Anterior Cervical Plate Systems [Verticor LTD, K103137… | 2000 |
| Kept off the family tree | K094570 | Synthes Anterior CSP System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K103137 | Venus Anterior Cervical PlateSummary page 1…K<000536 1 K<9457001, Venus Anterior Cervical Plate Systems [Verticor LTD, K103137], Spider Cervical Plating System [X-Spine Systems, K<0522921,… | 2011 |
| * | K052292 | Spider Cervical Plating (SCP) SystemSummary page 1…Systems [Verticor LTD, K103137], Spider Cervical Plating System [X-Spine Systems, K<0522921, Trestle Anterior Cervical Plating System [Alphatec,… | 2005 |
| * | K102820 | Appliance, Fixation, Spinal Intervertebral BodySummary page 1…2921, Trestle Anterior Cervical Plating System [Alphatec, K102820], and SmartLox Anterior Cervical Plate [Captival.… | 2010 |
| * | — | SmartLox Anterior Cervical Plate Named without a submission number |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-0921-2013 | Employee error | Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K133245 (Genesys Spine, 2014) has gone furthest, with 1 descendant of its own.
- 39 other devices also cite its predicate K000536.
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. 2011, 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 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…
Read the full statement (106 words)
The Genesys Spine Anterior Cervical Plate 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/K111132 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111132: Genesys Spine 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/K111132
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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