510(k) · Cleared
ClearedPioneer Lateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 7, 2012 as substantially equivalent to K070273 (Nuvasive, Inc., 2007) and 1 other predicate after a 59-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- May 7, 2012
- Review
- 59 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K022791 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- 2 generations backK063158 Synthes Antegra SystemSynthes Spine Co.Lp · 2006
- 1 generation backK090222 Pioneer Lumbar Plate SystemPioneer Surgical Technology · 2009
- This deviceK120724 Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| −2 | K063158 | Synthes Antegra System | Synthes Spine Co.Lp | 2006 | — |
| −1 | K090222 | Pioneer Lumbar Plate System | Pioneer Surgical Technology | 2009 | — |
| 0 (this device) | 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 |
| 2007 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070273 | Modification to Nuvasive Lateral Plate SystemSummary page 1…fixation orthosis Product Code: KWQ; Panel Code: 87 Predicate Devices: 4NuVasive Lateral Plate System (K070273) Quantum Spinal System (KOSOS IS) Pioneer Lumbar Plate System (K090222)… | 2007 |
| Kept off the family tree | K080815 | FDA’s K080815 is Tosca II Anterior Cervical Plate System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K090222 | Pioneer Lumbar Plate SystemSummary page 1…s: 4NuVasive Lateral Plate System (K070273) Quantum Spinal System (KOSOS IS) Pioneer Lumbar Plate System (K090222) Description: The Pioneer Lateral Plate System consists of an assortment of plates an… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K070273.
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. 2012, 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 Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120724: Pioneer Lateral 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/K120724
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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