510(k) · Cleared
ClearedCenterpiece Plate Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Cleared on Dec 13, 2021 as substantially equivalent to K050082 (Medtronic Sofamor Danek, Inc., 2005) after a 131-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Dec 13, 2021
- Review
- 131 days
- Class
- Class II
- Product code
- NQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850631 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK850631 Kirschner Orthopedic Wire, Eyelet Cerclage WiresKirschner Medical Corp. · 1985
- 1 generation backK050082 Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2005
- This deviceK212428 Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
- Descendant · cites it directly · 0 of its ownK252930 AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850631 | Kirschner Orthopedic Wire, Eyelet Cerclage Wires | Kirschner Medical Corp. | 1985 | — |
| −1 | K050082 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2005 | — |
| 0 (this device) | K212428 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek | 2021 | — |
| +1 | K252930 | AQUA Laminoplasty Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NQW? 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 NQW device
- #1 K243137 Curiteva Porous PEEK Laminoplasty Systemscore 13.1 · 7 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 |
|---|---|---|---|
| * | K050082 | Centerpiece Plate Fixation SystemSummary page 4…sis Classification: Class II Product Code: NQW III. Predicate Devices: Primary Predicate: (K050082, S.E. 06/06/2005) The predicate devices have not been subject to a design-related recall. IV. Device Description:… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252930 | AQUA Laminoplasty Systems | 2026 | 0 |
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 36 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252930 (ZheJiang Decans Medical Devices Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K050082.
How does its category compare?
All NQW devicesNQW Orthosis, Spine, Plate, Laminoplasty, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NQW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQW
84in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQW
No recall names NQW since 2007.
Adverse event reports per year · NQW
33in 2025
MAUDE reports naming product code NQW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 3 | 120 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 120 | 0 | 1 |
| 2013 | 3 | 84 | 0 | 49 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 2 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212428: Centerpiece Plate Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212428
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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