510(k) · Cleared
ClearedPioneer Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 28, 2009 as substantially equivalent to K063158 (Synthes Spine Co.Lp, 2006) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K022791 (2002). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- 1 generation backK063158 Synthes Antegra SystemSynthes Spine Co.Lp · 2006
- This deviceK090222 Pioneer Lumbar Plate SystemPioneer Surgical Technology · 2009
- Descendant · cites it directly · 1 of its ownK182808 Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK230721 ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK120724 Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc. · 2018 · cites it directly1descendant
- K230721ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023 · 2 generations on0descendants
- K120724Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| −1 | K063158 | Synthes Antegra System | Synthes Spine Co.Lp | 2006 | — |
| 0 (this device) | K090222 | Pioneer Lumbar Plate System | Pioneer Surgical Technology | 2009 | — |
| +1 | K182808 | Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K120724 | Pioneer Lateral Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K063158 | Synthes Antegra SystemSummary page 1…d. Performance and SE Comparisons of device performance data, materials, indications Determination: and design/function to predicate devices, K063158 &K041167, were provided in making a determination of substantial eq… | 2006 |
| * | K041167 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…Performance and SE Comparisons of device performance data, materials, indications Determination: and design/function to predicate devices, K063158 &K041167, were provided in making a determination of substantial equivalence… | 2004 |
What descends from it? (3)
2 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 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K182808 (Alphatec Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K063158.
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. 2009, 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 Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -SI) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor…
Read the full statement (132 words)
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -SI) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090222: Pioneer Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090222
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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