510(k) · Cleared
ClearedPyramid Anterior Plate Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 29, 2002 as substantially equivalent to K922543 (Sofamor Danek Mfg., Inc., 1993) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1993. 248 later devices descend from it.
- Decided
- Jan 29, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K922543 (1993). 3 ancestors in all. 248 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- This deviceK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 211 of its ownK052546 Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006
- Descendant · cites it directly · 211 of its ownK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- Descendant · 2 generations on · 165 of its ownK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- Descendant · cites it directly · 161 of its ownK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- Descendant · 2 generations on · 159 of its ownK091044 Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 248 · See all- K052546Aegis Anterior Lumbar Plate SystemDepuy Spine, Inc. · 2006 · cites it directly211descendants
- K043548Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005 · cites it directly211descendants
- K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006 · 2 generations on165descendants
- K070922Modification to Spinal Usa VBR SystemSpinal USA · 2007 · cites it directly161descendants
- K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA · 2009 · 2 generations on159descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| 0 (this device) | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K052546 | Aegis Anterior Lumbar Plate System | Depuy Spine, Inc. | 2006 | — |
| +1 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| +2 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| +1 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| +2 | K091044 | Spinal Usa Anterior Lumbar Plate System | Spinal USA | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 15 | 0 |
| 2020 | 22 | 0 |
| 2021 | 16 | 0 |
| 2022 | 28 | 0 |
| 2023 | 35 | 0 |
| 2024 | 29 | 0 |
| 2025 | 28 | 0 |
| 2026 | 36 | 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? (3)
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 |
|---|---|---|---|
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 1…YRAMID™ ANTERIOR PLATE Fixation System Spinal Intervertebral Body Fixation Orthosis, Class II The PYRAMID™ ANTERIOR PLATE Fixation System is substantially equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation System, which was cleared on May 19, 1993 and the BUTTERFLY™ PLATE Fixation System (… | 1993 |
| * | K010632 | Butterfly Plate Function SystemSummary page 1…m is substantially equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation System, which was cleared on May 19, 1993 and the BUTTERFLY™ PLATE Fixation System (K010632) which was cleared on May 31, 2001. The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting… | 2001 |
| * | K994122 | Bone Graft Washer, Model 9090114 - 9090118Summary page 2…ion System is substantially equivalent to K922543, Sofamor Danek ZPLATE-ATL™ Anterior Fixation System (SE 5/19/93) and to the Medtronic Sofamor Danek BONE GRAFT WASHER (K994122 SE 12/06/99). o RIALTy o DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administrati… | 2000 |
What descends from it? (248)
See all 24812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052546 | Aegis Anterior Lumbar Plate System | 2006 | 211 |
| K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | 2005 | 211 |
| K070922 | Modification to Spinal Usa VBR System | 2007 | 161 |
| K091253 | Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate… | 2009 | 73 |
| K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate System | 2008 | 50 |
| K062836 | Citadel Anterior Lumbar Plate System | 2006 | 50 |
| K124034 | Mectalif Anterior | 2013 | 11 |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | 2020 | 10 |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS… | 2017 | 2 |
| K051764 | T-Plate Anterior Fixation System | 2005 | 1 |
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?
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 Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of…
Read the full statement (137 words)
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
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/K013665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013665: Pyramid Anterior Plate Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013665
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026