510(k) · Cleared
ClearedMeta-C Cervical Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 12, 2014 as substantially equivalent to K000742 (Synthes Spine, 2000) and 4 other predicates after a 120-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 12, 2014
- Review
- 120 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K953730 (1995). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK953730 Codman Anterior Cervical Plate SystemJohnson & Johnson Professionals, Inc. · 1995
- 5 generations backK013877 Codman Slim-Loc SystemCodman & Shurtleff, Inc. · 2001
- 4 generations backK040655 Swift Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 3 generations backK072546 Swift Plus Anterior Cervical Plate SystemDepuy Spine, Inc. · 2007
- 2 generations backK080646 C-Tek Maxan Anterior Cervical Plate SystemBiomet Spine · 2008 · Recalled
- 1 generation backK081038 Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2008 · Recalled
- This deviceK140361 Meta-C Cervical PlateMedacta International · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953730 | Codman Anterior Cervical Plate System | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −5 | K013877 | Codman Slim-Loc System | Codman & Shurtleff, Inc. | 2001 | — |
| −4 | K040655 | Swift Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −3 | K072546 | Swift Plus Anterior Cervical Plate System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080646 | C-Tek Maxan Anterior Cervical Plate System | Biomet Spine | 2008 | 2 |
| −1 | K081038 | Atlantis Anterior Cervical Plate System | Medtronic Sofamor Danek | 2008 | 3 |
| 0 (this device) | K140361 | Meta-C Cervical Plate | Medacta International | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K000742 | Synthes Anterior CSLP SystemSummary page 1…rvertebral body 21 CFR 888.3060 Class 11 Product Code(s): KWQ Predicate Devices: 510O(k) Product 510(k) Holder Clearance Date K000742 CSILP Synthes 3/29/2000 K001794 Anterior Cervical Plate E… | 2000 |
| * | K001794 | Ebi Anterior Cervical Plate SystemSummary page 1…510O(k) Product 510(k) Holder Clearance Date K000742 CSILP Synthes 3/29/2000 K001794 Anterior Cervical Plate EBI 7/12/2000 K974706 ABC Plate Aesc… | 2000 |
| * | K974706 | Aesculap Abc Cervical Plating SystemSummary page 1…K000742 CSILP Synthes 3/29/2000 K001794 Anterior Cervical Plate EBI 7/12/2000 K974706 ABC Plate Aesculap 3/1 3/1 998 K050451 Vectra S… | 1998 |
| * | K050451 | Synthes Vectra SystemSummary page 1…K001794 Anterior Cervical Plate EBI 7/12/2000 K974706 ABC Plate Aesculap 3/1 3/1 998 K050451 Vectra Synthes 3/24/2005 K081038 Atlantis Medt… | 2005 |
| * | K081038 | Atlantis Anterior Cervical Plate SystemSummary page 1…K974706 ABC Plate Aesculap 3/1 3/1 998 K050451 Vectra Synthes 3/24/2005 K081038 Atlantis Medtronic 8/15/2008… | 2008 |
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 19 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 15 other devices also cite its predicate K000742.
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. 2014, 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 Mecta-C plate system is intended for anterior Interbody screw/plate fixation from C2 to Ti. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with; 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosisor scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140361: Meta-C 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/K140361
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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