510(k) · Cleared
ClearedCODA™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 20, 2023 as substantially equivalent to K222493 (Pioneer Surgical Technology, Inc., 2022) after a 75-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 20, 2023
- Review
- 75 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953730 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 4 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 3 generations backK052552 Hybrid Anterior Cervical Plate SystemDepuy Spine, Inc. · 2005 · Recalled
- 2 generations backK103491 Skyline Anterior Cervical Plate SystemA Johnson & Johnson Company · 2011
- 1 generation backK222493 CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. · 2022
- This deviceK230993 CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −3 | K052552 | Hybrid Anterior Cervical Plate System | Depuy Spine, Inc. | 2005 | 7 |
| −2 | K103491 | Skyline Anterior Cervical Plate System | A Johnson & Johnson Company | 2011 | — |
| −1 | K222493 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2022 | — |
| 0 (this device) | K230993 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | 2023 | — |
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 |
|---|---|---|---|
| * | K222493 | CODA™ Anterior Cervical Plate SystemSummary page 4…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K222493 11 CODA ™ Anterior Cervical Plate System K… | 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 28 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 5 ancestors has 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 CODA™ Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include:
degenerative disc disease (DDD) (defined as 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),
tumor, pseudoarthrosis, and failed previous fusion.
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/K230993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230993: CODA™ 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/K230993
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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