510(k) · Cleared
ClearedM-2 Anterior Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 1, 1997 after a 72-day review. The FDA summary names its predicate without a number. 221 later devices descend from it.
- Decided
- Oct 1, 1997
- Review
- 72 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
221 later devices descend from it, 5 citing it directly.
- This deviceK972718 M-2 Anterior Plate SystemAcromed Corp. · 1997
- Descendant · cites it directly · 211 of its ownK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- Descendant · 2 generations on · 161 of its ownK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- Descendant · 3 generations on · 159 of its ownK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
- Descendant · 2 generations on · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
- Descendant · 4 generations on · 113 of its ownK101255 Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010
Showing 5 of 221 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 221 · See all- K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006 · cites it directly211descendants
- K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007 · 2 generations on161descendants
- K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009 · 3 generations on159descendants
- K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · 2 generations on113descendants
- K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2010 · 4 generations on113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972718 | M-2 Anterior Plate System | Acromed Corp. | 1997 | — |
| +1 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| +2 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| +3 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
| +2 | K121791 | Zou Anterior Lumbar Plate System | Corelink, LLC | 2012 | — |
| +4 | K101255 | Alphatec Spine Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 13 | 0 |
| 2020 | 17 | 0 |
| 2021 | 15 | 0 |
| 2022 | 24 | 0 |
| 2023 | 34 | 0 |
| 2024 | 29 | 0 |
| 2025 | 27 | 0 |
| 2026 | 35 | 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 |
|---|---|---|---|
| * | — | Z-Plate Anterior Fixation System Named without a submission number |
What descends from it? (221)
See all 2215 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K052546 (Depuy Spine, Inc., 2006) has gone furthest, with 211 descendants of its own.
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.
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 M-2 Anterior Plate System is intended for use in:
1. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Burst fractures/ trauma
Tumor
Anterior fusion following failed posterior operations
Unsuccessful previous anterior surgery
Lordotic deformities of the spine
The intended levels for treatment with the M-2 Anterior Plate System are T3 to L3. In order to treat levels T3 to L3, plate attachment is from T2 to 14. The M-2 Plate System is intended to treat one motion segment per construct.
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/K972718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972718: M-2 Anterior Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972718
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