510(k) · Cleared
Recalled · 2005Pioneer Surgical Technology Quantum Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 23, 2004 after an 80-day review. The FDA summary names no predicate by number. 197 later devices descend from it. It has been recalled once.
- Decided
- Jul 23, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 0
197 later devices descend from it, 6 citing it directly.
- This deviceK041167 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2004
- Descendant · cites it directly · 193 of its ownK070551 Modification to: Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2007
- Descendant · cites it directly · 178 of its ownK070973 Quantum Spinal SystemPioneer Surgical Technology · 2007
- Descendant · 2 generations on · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- Descendant · 2 generations on · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- Descendant · 3 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
Showing 5 of 197 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 197 · See all- K070551Modification to: Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2007 · cites it directly193descendants
- K070973Quantum Spinal SystemPioneer Surgical Technology · 2007 · cites it directly178descendants
- K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · 2 generations on177descendants
- K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · 2 generations on174descendants
- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 3 generations on136descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041167 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2004 | — |
| +1 | K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2007 | — |
| +1 | K070973 | Quantum Spinal System | Pioneer Surgical Technology | 2007 | — |
| +2 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| +2 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| +3 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 16 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 25 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (197)
See all 1976 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal System | 2007 | 193 |
| K070973 | Quantum Spinal System | 2007 | 178 |
| K080504 | Pioneer Lowtop Spinal Rod System | 2008 | 92 |
| K080026 | Quantum-Mis Cannulated System | 2008 | 12 |
| K101790 | Quantum Spinal System, Quantum Mis | 2011 | 10 |
| K090222 | Pioneer Lumbar Plate System | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2005 | Not classified | Z-0021-06 | Other | Screw may be incorrectly etched as to length. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070551 (Pioneer Surgical Technology, 2007) has gone furthest, with 193 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (TI - S2) or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by…
Read the full statement (97 words)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (TI - S2) or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041167: Pioneer Surgical Technology Quantum Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041167
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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