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 Apr 3, 2018 as substantially equivalent to K142699 (Stryker Corporation, 2014) and 4 other predicates after a 103-day review. Its family tree reaches back 8 generations to 1999. 4 later devices descend from it.
- Decided
- Apr 3, 2018
- Review
- 103 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K990745 (1999). 44 ancestors in all, the oldest K922543 (1993). 4 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 5 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 4 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 3 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 2 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 1 generation backK142699 LITe Plate SystemStryker Corporation · 2014
- This deviceK173885 Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 2018
- Descendant · cites it directly · 1 of its ownK192678 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
- Descendant · cites it directly · 0 of its ownK233360 Curiteva Thoracolumbar Plate SystemCuriteva, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231715 MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
Most influential descendants
Showing 4 of 4 · See all- K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine · 2019 · cites it directly1descendant
- K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026 · cites it directly0descendants
- K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc. · 2024 · cites it directly0descendants
- K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −5 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −4 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −3 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −2 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −1 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| 0 (this device) | K173885 | Genesys Spine Binary Lumbar Plate System | Genesys Spine | 2018 | — |
| +1 | K192678 | Genesys Spine Binary® Lumbar Plate System | Genesys Spine | 2019 | — |
| +1 | K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
| +1 | K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | 2024 | — |
| +1 | K231715 | MONDRIAN™ Anterior Lumbar Plate System | Ctl Medical Corporation | 2024 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K142699 | LITe Plate SystemSummary page 4…WQ Classification Panel: Orthopedic Devices Panel Legally Marketed Primary Predicate: (unmodified) devices to Stryker LITe Plate System (K142699) Which Substantial Additional Predicate(s): Equivalence is Claimed: Spinal USA AccuFit Plate System (K09104… | 2014 |
| * | K091044 | Spinal Usa Anterior Lumbar Plate SystemSummary page 4…ces to Stryker LITe Plate System (K142699) Which Substantial Additional Predicate(s): Equivalence is Claimed: Spinal USA AccuFit Plate System (K091044), Synthes Anterior Tension Band System (K022791), Depuy Aegis Ant… | 2009 |
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 4…Additional Predicate(s): Equivalence is Claimed: Spinal USA AccuFit Plate System (K091044), Synthes Anterior Tension Band System (K022791), Depuy Aegis Anterior Lumbar Plate (K052546), Synthes TSLP Thora… | 2002 |
| * | K052546 | Aegis Anterior Lumbar Plate SystemSummary page 4…late System (K091044), Synthes Anterior Tension Band System (K022791), Depuy Aegis Anterior Lumbar Plate (K052546), Synthes TSLP Thoracolumbar Plate (K020244) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTI… | 2006 |
| * | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP)Summary page 4…ion Band System (K022791), Depuy Aegis Anterior Lumbar Plate (K052546), Synthes TSLP Thoracolumbar Plate (K020244) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Genesys Spine Binary Lumbar Plate System consists of an assort… | 2002 |
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 19 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K192678 (Genesys Spine, 2019) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K142699.
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. 2018, 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 (L1-S1) spine instability as a result of fracture (including dislocation…
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 (L1-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/K173885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173885: 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/K173885
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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