510(k) · Cleared
ClearedRomeo Posterior Osteosynthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 28, 2010 as substantially equivalent to K081165 (Spineart, 2008) and 1 other predicate after a 43-day review. Its family tree reaches back 3 generations to 2001. 16 later devices descend from it.
- Decided
- Jul 28, 2010
- Review
- 43 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011437 (2001). 4 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
- 2 generations backK081165 Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008
- 1 generation backK093170 Romeo Posterior Osteosynthesis SystemSpineart · 2009
- This deviceK101678 Romeo Posterior Osteosynthesis SystemSpineart · 2010
- Descendant · cites it directly · 13 of its ownK112108 Romeo Posterior Osteosynthesis SystemSpineart · 2011
- Descendant · cites it directly · 13 of its ownK111127 Romeo Posterior Osteosynthesis SystemSpineart · 2011
- Descendant · cites it directly · 12 of its ownK130267 Romeo Posterior Osteosynthesis SystemSpineart · 2013
- Descendant · cites it directly · 11 of its ownK141835 Romeo Posterior Osteosynthesis System Prebent Cross-Connectors…Spineart · 2014
- Descendant · 2 generations on · 10 of its ownK151695 Romeo posterior osteosynthesis systemSpineart · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112108Romeo Posterior Osteosynthesis SystemSpineart · 2011 · cites it directly13descendants
- K111127Romeo Posterior Osteosynthesis SystemSpineart · 2011 · cites it directly13descendants
- K130267Romeo Posterior Osteosynthesis SystemSpineart · 2013 · cites it directly12descendants
- K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart · 2014 · cites it directly11descendants
- K151695Romeo posterior osteosynthesis systemSpineart · 2015 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | Interpore Cross Intl. | 2001 | — |
| −2 | K081165 | Ellipse Lumbar Posterior Osteosynthesis System | Spineart | 2008 | — |
| −1 | K093170 | Romeo Posterior Osteosynthesis System | Spineart | 2009 | — |
| 0 (this device) | K101678 | Romeo Posterior Osteosynthesis System | Spineart | 2010 | — |
| +1 | K112108 | Romeo Posterior Osteosynthesis System | Spineart | 2011 | — |
| +1 | K111127 | Romeo Posterior Osteosynthesis System | Spineart | 2011 | — |
| +1 | K130267 | Romeo Posterior Osteosynthesis System | Spineart | 2013 | — |
| +1 | K141835 | Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods | Spineart | 2014 | — |
| +2 | K151695 | Romeo posterior osteosynthesis system | Spineart | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K081165 | Ellipse Lumbar Posterior Osteosynthesis SystemSummary page 1…ion codes KWP Spinal interlaminal fixation orthosis Device panel ORTHOPEDIC maretedELLIPSE posterior osteosynthesis system (K081165) and Legaly predcat devcesROMEO posterior osteosynthesis system (KOYS3170) man… | 2008 |
| * | K093170 | Romeo Posterior Osteosynthesis SystemSummary page 1…ystem (KOYS3170) manufactured by SPINEART The modifications to ROMEO posterior osteosynthesis system (K(081165 & K093170) manufactured by SPINEART consist of addition of 4.0 and 8.0 mm in diameter polyaxial Description… | 2009 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112108 | Romeo Posterior Osteosynthesis System | 2011 | 13 |
| K111127 | Romeo Posterior Osteosynthesis System | 2011 | 13 |
| K130267 | Romeo Posterior Osteosynthesis System | 2013 | 12 |
| K141835 | Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods | 2014 | 11 |
| K140948 | Romeo Posterior Osteosynthesis System | 2014 | 10 |
| K172101 | ROMEO® 2 Posterior Osteosynthesis System | 2017 | 9 |
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 9 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112108 (Spineart, 2011) has gone furthest, with 13 descendants of its own.
- 11 other devices also cite its predicate K081165.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
ROMEO posterior osteosynthesis 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-Si vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101678: Romeo Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101678
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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