510(k) · Cleared
ClearedOmnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnia Medical, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 12, 2023 as substantially equivalent to K221728 (Stryker Corporation, 2022) after a 54-day review. Its family tree reaches back 10 generations to 1999.
- Decided
- Apr 12, 2023
- Review
- 54 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K990745 (1999). 160 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 2 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 1 generation backK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- This deviceK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK062407 Gateway Thoracolumbar Plate SystemGlobus Medical, Inc. · 2006
- 4 generations backK062836 Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc. · 2006
- 3 generations backK142699 LITe Plate SystemStryker Corporation · 2014
- 2 generations backK150449 LITe Plate SystemStryker Corp. · 2015
- 1 generation backK221728 Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System…Stryker Corporation · 2022
- This deviceK230424 Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical…Omnia Medical, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K062407 | Gateway Thoracolumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −4 | K062836 | Citadel Anterior Lumbar Plate System | Globus Medical, Inc. | 2006 | — |
| −3 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| −2 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| −1 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™… | Stryker Corporation | 2022 | — |
| 0 (this device) | K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical… | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 12 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Summary page 4…CFR 888.3060) Device Classification: Class II Reviewing Panel: Orthopedic Product Code: KWQ Primary Predicate Device: K221728 Stryker LITe® Plate System The primary predicate device has never been subject to a recall. Dev… | 2022 |
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 24 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 18 of the 160 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. 2023, 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 Coupler-A™ and Coupler-L™ Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or…
Read the full statement (122 words)
The Coupler-A™ and Coupler-L™ Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
* Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
* Pseudoarthrosis;
* Spondylolysis;
* Spondylolisthesis;
* Spinal stenosis;
* Tumors;
* Trauma (i.e. Fractures or Dislocation)
* Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
* Failed Previous Fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral 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/K230424
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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