510(k) · Cleared
ClearedPioneer 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 Mar 20, 2008 as substantially equivalent to K070973 (Pioneer Surgical Technology, 2007) and 1 other predicate after a 24-day review. Its family tree reaches back 5 generations to 2000. 174 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K992147 (2000). 15 ancestors in all, the oldest K000319 (2000). 174 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 4 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 3 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 2 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 1 generation backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- This deviceK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- Descendant · cites it directly · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- Descendant · 2 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 3 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · cites it directly · 90 of its ownK093692 Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
- Descendant · 2 generations on · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
Showing 5 of 174 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 174 · See all- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · cites it directly136descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 2 generations on133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 3 generations on132descendants
- K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010 · cites it directly90descendants
- K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on89descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −4 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −3 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −2 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −1 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| 0 (this device) | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| +1 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| +2 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +3 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +1 | K093692 | Quantum/ Streamline Spinal System Model 02-Series and 10-Series | Pioneer Surgical Technology | 2010 | — |
| +2 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K070973 | Quantum Spinal SystemSummary page 1…Spinal System - §888.3070, Class Ill. Product Codes: NKB, KWQ, KWP, MNIA, MINI, Panel Code 87 Predicate Device: K070973 - Quantum Spinal System (SE date - July 3, 2007) K072 187 - Pionmeer LowTop (SE date - October 12,… | 2007 |
| * | K072187 | Pioneer Lowtop Spinal Rod SystemSummary page 1…s: NKB, KWQ, KWP, MNIA, MINI, Panel Code 87 Predicate Device: K070973 - Quantum Spinal System (SE date - July 3, 2007) K072 187 - Pionmeer LowTop (SE date - October 12, 2007) Intended Use: The Quantum Spinal System components are non-cervic… | 2007 |
What descends from it? (174)
See all 1748 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100297 | Pass LP Spinal System | 2010 | 136 |
| K093692 | Quantum/ Streamline Spinal System Model 02-Series and 10-Series | 2010 | 90 |
| K101790 | Quantum Spinal System, Quantum Mis | 2011 | 10 |
| K093771 | Quantum/Streamline TL Mis Spinal System | 2010 | 8 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
| K081296 | Preference Pedicle Screw System | 2008 | 3 |
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 8 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K100297 (Medicrea Technologies, 2010) has gone furthest, with 136 descendants of its own.
- 7 other devices also cite its predicate K070973.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 an adjunct to fusion 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…
Read the full statement (109 words)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion 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, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080518: 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/K080518
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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