510(k) · Cleared
ClearedRogozinski Spinal Rod System Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 14, 1995 after an 874-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.
- Decided
- Jun 14, 1995
- Review
- 874 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK930298 Rogozinski Spinal Rod System ScrewSmith & Nephew Richards, Inc. · 1995
- Descendant · cites it directly · 27 of its ownK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · 2 generations on · 14 of its ownK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
- Descendant · 3 generations on · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
- Descendant · 3 generations on · 7 of its ownK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998 · cites it directly27descendants
- K031595U & I America Spinal Hook SystemU&I Corp., America · 2003 · 2 generations on14descendants
- K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · 2 generations on9descendants
- K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · 3 generations on8descendants
- K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930298 | Rogozinski Spinal Rod System Screw | Smith & Nephew Richards, Inc. | 1995 | — |
| +1 | K983904 | Rogozinski Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +2 | K031595 | U & I America Spinal Hook System | U&I Corp., America | 2003 | 3 |
| +2 | K100757 | Tilock Pedicle Screw System | Genesys Spine | 2010 | 1 |
| +3 | K103671 | Genesys Spine Tilock System | Genesys Spine | 2011 | — |
| +3 | K152039 | Genesys Spine TiLock2 Spinal System | Genesys Spine | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 282 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, K983904 (United States Surgical, A Division of Tyco Healthc, 1998) has gone furthest, with 27 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 | — |
https://510kreport.com/device/K930298 · printed Nov 3, 2026
Cite this page
510(k) Report. “K930298: Rogozinski Spinal Rod System Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930298
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026