510(k) · Cleared
ClearedModified Uss Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jun 4, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 668 devices in its family, counting itself, have a Class I recall. 667 later devices descend from it.
- Decided
- Jun 4, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
667 later devices descend from it, 5 citing it directly. 2 of the 668 devices in this family, counting this one, have a Class I recall.
- This deviceK010658 Modified Uss Fracture SystemSynthes (Usa) · 2001
- Descendant · cites it directly · 659 of its ownK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 350 of its ownK082914 ClampfixSynthes Spine · 2008
- Descendant · cites it directly · 349 of its ownK090605 ClampfixSynthes (Usa) · 2009
- Descendant · 2 generations on · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
Showing 5 of 667 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 667 · See all- K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · cites it directly659descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
- K082914ClampfixSynthes Spine · 2008 · cites it directly350descendants
- K090605ClampfixSynthes (Usa) · 2009 · cites it directly349descendants
- K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · 2 generations on348descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010658 | Modified Uss Fracture System | Synthes (Usa) | 2001 | — |
| +1 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| +2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K082914 | Clampfix | Synthes Spine | 2008 | — |
| +1 | K090605 | Clampfix | Synthes (Usa) | 2009 | — |
| +2 | K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | Synthes Spine | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 1 |
| 2011 | 8 | 0 |
| 2012 | 21 | 0 |
| 2013 | 29 | 0 |
| 2014 | 36 | 0 |
| 2015 | 45 | 0 |
| 2016 | 40 | 0 |
| 2017 | 47 | 0 |
| 2018 | 47 | 0 |
| 2019 | 34 | 0 |
| 2020 | 41 | 0 |
| 2021 | 32 | 1 |
| 2022 | 43 | 0 |
| 2023 | 67 | 0 |
| 2024 | 65 | 0 |
| 2025 | 52 | 0 |
| 2026 | 50 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (667)
See all 6675 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K082572 (Synthes Spine, 2008) has gone furthest, with 659 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010658 · printed Nov 3, 2026
Cite this page
510(k) Report. “K010658: Modified Uss Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010658
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026