510(k) · Cleared
ClearedPioneer Lowtop Spinal Rod 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 K072187 (Pioneer Surgical Technology, 2007) and 4 other predicates after a 24-day review. Its family tree reaches back 5 generations to 2000. 92 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K992147 (2000). 15 ancestors in all, the oldest K000319 (2000). 92 later devices descend from it, 2 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 deviceK080504 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2008
- 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
- Descendant · 3 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 4 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- Descendant · 5 generations on · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- 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
- K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 3 generations on88descendants
- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 4 generations on82descendants
- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · 5 generations on73descendants
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) | K080504 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2008 | — |
| +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 | — |
| +3 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +4 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| +5 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 15 | 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? (5)
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 |
|---|---|---|---|
| * | K072187 | Pioneer Lowtop Spinal Rod SystemSummary page 1…Pedicle Screw Spinal System. The product codes are NKB, KWP, KWQ, MNH, and MNI. The Panel code is 87. Predicate Device: K072187 - Pioneer LowTop Spinal Rod System (SE Date 10/12107)… | 2007 |
| * | K070933 | Lowtop Pedicle Screw SystemSummary page 1…Predicate Device: K072187 - Pioneer LowTop Spinal Rod System (SE Date 10/12107) K070933 - Sanacor LowTop Pedicle Screw System (SE Date 6/13107)… | 2007 |
| * | K070973 | Quantum Spinal SystemSummary page 1…K070933 - Sanacor LowTop Pedicle Screw System (SE Date 6/13107) K070973 - Quantum Spinal System (SE Date July 3, 2007) K070551 - Quantum Spinal System (SE date - March 29,… | 2007 |
| * | K070551 | Modification to: Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…6/13107) K070973 - Quantum Spinal System (SE Date July 3, 2007) K070551 - Quantum Spinal System (SE date - March 29, 2007)… | 2007 |
| * | K041167 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 1…K070551 - Quantum Spinal System (SE date - March 29, 2007) K041167 - Quantum Spinal System (SE date - July 23, 2004) Intended Use: The Pioneer LowTop Spinal Rod System components a… | 2004 |
What descends from it? (92)
See all 922 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 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, K093692 (Pioneer Surgical Technology, 2010) has gone furthest, with 90 descendants of its own.
- 3 other devices also cite its predicate K072187.
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 Pioneer LowTop Spinal Rod 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…
Read the full statement (111 words)
The Pioneer LowTop Spinal Rod 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, pseudoarthosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080504 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080504: Pioneer Lowtop Spinal Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080504
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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