510(k) · Cleared
ClearedGenesys Spine Binary® Lumbar 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 Oct 24, 2019 as substantially equivalent to K173885 (Genesys Spine, 2018) after a 28-day review. Its family tree reaches back 9 generations to 1999. 1 later device descends from it.
- Decided
- Oct 24, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K990745 (1999). 45 ancestors in all, the oldest K922543 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK173885 Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 2018
- This deviceK192678 Genesys Spine Binary® Lumbar Plate SystemGenesys Spine · 2019
- Descendant · cites it directly · 0 of its ownK251940 PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 1 generation backK173885 Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 2018
- This deviceK192678 Genesys Spine Binary® Lumbar Plate SystemGenesys Spine · 2019
Most influential descendants
Showing 1 of 1 · See all- K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −1 | K173885 | Genesys Spine Binary Lumbar Plate System | Genesys Spine | 2018 | — |
| 0 (this device) | K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | 2019 | — |
| +1 | K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K173885 | Genesys Spine Binary Lumbar Plate SystemSummary page 4…pedic and Rehabilitation Devices Panel Legally Marketed Primary Predicate: (unmodified) devices to Binary Lumbar Plate System (Genesys Spine – K173885) Which Substantial Equivalence is Claimed: PURPOSE OF THE 510(K) The intent of this Special 510(k) is to: 1. Add addit… | 2018 |
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 |
|---|---|---|---|
| K251940 | PathLoc Lumbar Plate System | 2026 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K251940 (L&K BIOMED Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K173885.
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® Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (I.1-S1) spine instability as a result of fracture (including…
Read the full statement (105 words)
The Genesys Spine Binary® Lumbar Plate System is indicated as additional support during fusion via a lateral or
anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar
(T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment
of lumbar and lumbosacral (I.1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor,
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient
history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
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/K192678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192678: Genesys Spine Binary® Lumbar 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/K192678
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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