510(k) · Cleared
ClearedQuantum 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 3, 2007 as substantially equivalent to K041167 (Pioneer Surgical Technology, 2004) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 2003. 178 later devices descend from it.
- Decided
- Jul 3, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K031175 (2003). 4 ancestors in all. 178 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK031175 Click'x Monoaxial Screws and HooksSynthes (Usa) · 2003
- 1 generation backK052151 Synthes Pangea Monoaxial SystemSynthes Spine Co.Lp · 2005
- This deviceK070973 Quantum Spinal SystemPioneer Surgical Technology · 2007
- Descendant · cites it directly · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- Descendant · cites it directly · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- Descendant · 2 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- Descendant · 3 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 4 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · cites it directly177descendants
- K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · cites it directly174descendants
- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 2 generations on136descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 3 generations on133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 4 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031175 | Click'x Monoaxial Screws and Hooks | Synthes (Usa) | 2003 | — |
| −1 | K052151 | Synthes Pangea Monoaxial System | Synthes Spine Co.Lp | 2005 | — |
| 0 (this device) | K070973 | Quantum Spinal System | Pioneer Surgical Technology | 2007 | — |
| +1 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| +1 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| +2 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| +3 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +4 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 24 | 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? (4)
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 |
|---|---|---|---|
| * | K041167 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System, Class 111. Predicate Device: K041167 - Quantum Spinal System, K070551 - Quantum Spinal System, K052151 - Synthes Pangea Monoaxial System,… | 2004 |
| * | K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…hesis Spinal Fixation Device System and Pedicle Screw Spinal System, Class 111. Predicate Device: K041167 - Quantum Spinal System, K070551 - Quantum Spinal System, K052151 - Synthes Pangea Monoaxial System, K031175 -… | 2007 |
| * | K052151 | Synthes Pangea Monoaxial SystemSummary page 1…and Pedicle Screw Spinal System, Class 111. Predicate Device: K041167 - Quantum Spinal System, K070551 - Quantum Spinal System, K052151 - Synthes Pangea Monoaxial System, K031175 - Synthes Click'X Monoaxial System Intended Use:… | 2005 |
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…11. Predicate Device: K041167 - Quantum Spinal System, K070551 - Quantum Spinal System, K052151 - Synthes Pangea Monoaxial System, K031175 - Synthes Click'X Monoaxial System Intended Use: The Quantum Spinal System componen… | 2003 |
What descends from it? (178)
See all 1788 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072187 | Pioneer Lowtop Spinal Rod System | 2007 | 177 |
| K080518 | Pioneer Surgical Technology Quantum Spinal System | 2008 | 174 |
| K080504 | Pioneer Lowtop Spinal Rod System | 2008 | 92 |
| K093692 | Quantum/ Streamline Spinal System Model 02-Series and 10-Series | 2010 | 90 |
| K101790 | Quantum Spinal System, Quantum Mis | 2011 | 10 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K072187 (Pioneer Surgical Technology, 2007) has gone furthest, with 177 descendants of its own.
- 5 other devices also cite its predicate K041167.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 pedicle screw system (TI - S2), a posterior hook and sacral/iliac screw fixation system 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…
Read the full statement (104 words)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a pedicle screw system (TI - S2), a posterior hook and sacral/iliac screw fixation system 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/K070973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070973: 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/K070973
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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