510(k) · Cleared
ClearedOmnia Medical Coupler-C Anterior Cervical Plate
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 Mar 13, 2023 as substantially equivalent to K143626 (Zimmer Spine, Inc., 2015) and 3 other predicates after a 133-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Mar 13, 2023
- Review
- 133 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K953730 (1995). 53 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations between
- 3 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK182489 4CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
- This deviceK223321 Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023
Show all 9 generations
- Root · 9 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 8 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 7 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 6 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 5 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 4 generations backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- 3 generations backK130640 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK141632 Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc. · 2014 · Recalled
- 1 generation backK182489 4CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
- This deviceK223321 Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −8 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −7 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −6 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −4 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| −3 | K130640 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K141632 | Zevo (TM) Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2014 | 1 |
| −1 | K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | Solco Biomedical Co., Ltd. | 2019 | — |
| 0 (this device) | K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Summary page 4…888.3060) Device Classification: Class II Reviewing Panel: Orthopedic Product Code: KWQ Primary Predicate Device: K143626- Zimmer Spine Invizia Anterior Cervical Plate System The primary predicate device has never bee… | 2015 |
| * | K113329 | K2M, Pyrenees Cervical Plate SystemSummary page 4…vizia Anterior Cervical Plate System The primary predicate device has never been subject to a recall. Additional Predicates: K113329 K2M Pyrenees Cervical Plate System K183056 Globus ASSURE Anterior Cervical Plate System… | 2012 |
| * | K183056 | ASSURE® Anterior Cervical Plate SystemSummary page 4…imary predicate device has never been subject to a recall. Additional Predicates: K113329 K2M Pyrenees Cervical Plate System K183056 Globus ASSURE Anterior Cervical Plate System K182489 Solco 4CIS® Pinehurst Anterior Cervical Pl… | 2019 |
| * | K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemSummary page 4…K113329 K2M Pyrenees Cervical Plate System K183056 Globus ASSURE Anterior Cervical Plate System K182489 Solco 4CIS® Pinehurst Anterior Cervical Plate System Device Description: The Omnia Medical Coupler-C Anterior Cervical Plate sy… | 2019 |
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 28 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 13 of the 53 ancestors have a recall of any class.
- 3 other devices also cite its predicate K143626.
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 Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DDD, neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223321: Omnia Medical Coupler-C Anterior Cervical Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223321
Report an extraction error
Are you the manufacturer?
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