510(k) · Cleared
ClearedBinary® 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 Aug 29, 2019 as substantially equivalent to K133245 (Genesys Spine, 2014) after a 27-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Aug 29, 2019
- Review
- 27 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K922087 (1992). 52 ancestors in all, the oldest K792352 (1979). 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 backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- 1 generation backK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · Recalled
- This deviceK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
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 backK130427 Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2013
- 1 generation backK133245 Genesys Spine Anterior Cervical Plate II SystemGenesys Spine · 2014 · Recalled
- This deviceK192076 Binary® Anterior Cervical Plate SystemGenesys Spine · 2019
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 | K130427 | Pioneer Aspect Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2013 | — |
| −1 | K133245 | Genesys Spine Anterior Cervical Plate II System | Genesys Spine | 2014 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K133245 | Genesys Spine Anterior Cervical Plate II SystemSummary page 4…habilitation Devices Panel Legally Marketed devices | Primary Predicate: to Which Substantial Anterior Cervical Plate II System (Genesys Spine - Equivalence is Claimed: K133245) PURPOSE OF THE 510(K) The intent of this Special 510(k) is to: 1. Register additional Screws sizes to the components of the Bi… | 2014 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 52 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. 2019, 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 Binary 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…
Read the full statement (107 words)
The Genesys Spine Binary 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192076: Binary® 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/K192076
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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