510(k) · Cleared
ClearedLowtop Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanacor · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 13, 2007 as substantially equivalent to K031455 (Signus Medical, LLC, 2003) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 2000. 178 later devices descend from it.
- Decided
- Jun 13, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K992147 (2000). 8 ancestors in all, the oldest K000319 (2000). 178 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 2 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 1 generation backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- This deviceK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- Descendant · cites it directly · 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
- Descendant · 4 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
- Descendant · 5 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 · 2 generations on174descendants
- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 3 generations on136descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 4 generations on133descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 5 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −2 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −1 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| 0 (this device) | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| +1 | 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 | — |
| +4 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
| +5 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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 MNH? 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? (3)
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 |
|---|---|---|---|
| * | K031455 | Conklusion Pedicle Screw SystemSummary page 1…(s): The subject device is substantially equivalent to the following devices: Con~lusion Pedicle Screw System (K03 1455) Marketed and distributed by Signus Medical LLC Optima Pedicle Screw Sys… | 2003 |
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 1…sion Pedicle Screw System (K03 1455) Marketed and distributed by Signus Medical LLC Optima Pedicle Screw System (K020279) Marketed and distributed by Zimmer Spine OvalTwist Pedicle Screw System… | 2002 |
| * | K061577 | Ovaltwist Pedicle Screw SystemSummary page 1…Optima Pedicle Screw System (K020279) Marketed and distributed by Zimmer Spine OvalTwist Pedicle Screw System (K061577) Marketed and distributed by Signus Medical LLC Device Description: The LowTop Pedicle Screw… | 2006 |
What descends from it? (178)
See all 1782 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 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K072187 (Pioneer Surgical Technology, 2007) has gone furthest, with 177 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications:
* Spondylolisthesis
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
* Tumor
* Pseudoarthrosis
* Failed previous fusion
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 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/K070933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070933: Lowtop Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070933
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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