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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 12, 2007 as substantially equivalent to K070933 (Sanacor, 2007) and 1 other predicate after a 67-day review. Its family tree reaches back 4 generations to 2000. 177 later devices descend from it.
- Decided
- Oct 12, 2007
- Review
- 67 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K992147 (2000). 14 ancestors in all, the oldest K000319 (2000). 177 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 3 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 2 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 1 generation backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- This deviceK072187 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
- Descendant · cites it directly · 92 of its ownK080504 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2008
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 177 · See all- 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
- K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2008 · cites it directly92descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −3 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −2 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −1 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| 0 (this device) | 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 | — |
| +1 | K080504 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2008 | — |
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 | 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 MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K070933 | Lowtop Pedicle Screw SystemSummary page 1…, Class II Number & Code: Pedicle Screw System Product Code: MNI and MNH Predicate Device: K070933 - LowTop Pedicle Screw System (SE Date 6/13/07) K070973 - Quantum Spinal Rod System (SE Date… | 2007 |
| * | K070973 | Quantum Spinal SystemSummary page 1…Product Code: MNI and MNH Predicate Device: K070933 - LowTop Pedicle Screw System (SE Date 6/13/07) K070973 - Quantum Spinal Rod System (SE Date 7/3/07) Intended Use: The Pioneer LowTop Spinal Rod System is intend… | 2007 |
What descends from it? (177)
See all 1774 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 7 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K080518 (Pioneer Surgical Technology, 2008) has gone furthest, with 174 descendants of its own.
- 1 other device also cites its predicate K070933.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pioneer LowTop Spinal Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis…
Read the full statement (129 words)
The Pioneer LowTop Spinal Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072187: Pioneer Lowtop Spinal Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072187
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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