510(k) · Cleared
ClearedOvaltwist Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 14, 2006 after a 99-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 183 later devices descend from it.
- Decided
- Sep 14, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
183 later devices descend from it, 4 citing it directly.
- This deviceK061577 Ovaltwist Pedicle Screw SystemSignus Medizintechnik GmbH · 2006
- Descendant · cites it directly · 178 of its ownK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- Descendant · 2 generations on · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- Descendant · 3 generations on · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- Descendant · 4 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- Descendant · 5 generations on · 133 of its ownK110497 Pass LP Spinal SystemMedicrea International · 2011 · Recalled
Showing 5 of 183 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 183 · See all- K070933Lowtop Pedicle Screw SystemSanacor · 2007 · cites it directly178descendants
- K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · 2 generations on177descendants
- K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · 3 generations on174descendants
- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 4 generations on136descendants
- K110497Pass LP Spinal SystemMedicrea International · 2011 · 5 generations on133descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061577 | Ovaltwist Pedicle Screw System | Signus Medizintechnik GmbH | 2006 | — |
| +1 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| +2 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| +3 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| +4 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| +5 | K110497 | Pass LP Spinal System | Medicrea International | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (183)
See all 1834 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?
- Of its descendants, K070933 (Sanacor, 2007) has gone furthest, with 178 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.
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 OvalTwist 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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061577: Ovaltwist Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061577
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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