510(k) · Cleared
ClearedModificaton to: Pyramid +4 Anterior Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 30, 2008 as substantially equivalent to K013665 (Medtronic Sofamor Danek, Inc., 2002) and 1 other predicate after a 71-day review. Its family tree reaches back 4 generations to 1993. 50 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 71 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K922543 (1993). 7 ancestors in all. 50 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 3 generations backK014267 Butterfly Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 2 generations backK022070 Xantus Anterior Lateral Supplemental Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK071416 Pyramid +4 Anterior Lumbar Spine Plate SystemMedtronic Sofamor Danek USA, Inc. · 2007
- This deviceK080429 Modificaton to: Pyramid +4 Anterior Lumbar Plate SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · cites it directly · 46 of its ownK142699 LITe Plate SystemStryker Corporation · 2014
- Descendant · 2 generations on · 24 of its ownK150449 LITe Plate SystemStryker Corp. · 2015
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · 2 generations on · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 3 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K142699LITe Plate SystemStryker Corporation · 2014 · cites it directly46descendants
- K150449LITe Plate SystemStryker Corp. · 2015 · 2 generations on24descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
- K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · 2 generations on13descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −3 | K014267 | Butterfly Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −2 | K022070 | Xantus Anterior Lateral Supplemental Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K071416 | Pyramid +4 Anterior Lumbar Spine Plate System | Medtronic Sofamor Danek USA, Inc. | 2007 | — |
| 0 (this device) | K080429 | Modificaton to: Pyramid +4 Anterior Lumbar Plate System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +1 | K142699 | LITe Plate System | Stryker Corporation | 2014 | — |
| +2 | K150449 | LITe Plate System | Stryker Corp. | 2015 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +2 | K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020 | — |
| +3 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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? (2)
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 |
|---|---|---|---|
| * | K013665 | Pyramid Anterior Plate Fixation System | 2002 |
| * | K071416 | Pyramid +4 Anterior Lumbar Spine Plate SystemSummary page 2…similar previously cleared devices such as the PYRAMID® Anterior Plate Fixation System (KO 13665, SE 12/29/2002) and PYRAMID ® +4 Anterior Lumbar Plate System (K071416, SE 11/1/2007). e-4 ~c- c) === Page 3… | 2007 |
What descends from it? (50)
See all 504 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142699 (Stryker Corporation, 2014) has gone furthest, with 46 descendants of its own.
- 11 other devices also cite its predicate K013665.
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. 2008, 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 Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S 1) of the vascular structures or anterior lateral above the bifurcation (LI -L5) of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1)…
Read the full statement (151 words)
The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S 1) of the vascular structures or anterior lateral above the bifurcation (LI -L5) 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 as stated in the FDA summary.
https://510kreport.com/device/K080429 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080429: Modificaton to: Pyramid +4 Anterior Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080429
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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