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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 19, 2011 as substantially equivalent to K081165 (Spineart, 2008) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 2001. 13 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K011437 (2001). 5 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
- 3 generations backK081165 Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008
- 2 generations backK093170 Romeo Posterior Osteosynthesis SystemSpineart · 2009
- 1 generation backK101678 Romeo Posterior Osteosynthesis SystemSpineart · 2010
- This deviceK112108 Romeo Posterior Osteosynthesis SystemSpineart · 2011
- Descendant · cites it directly · 12 of its ownK130267 Romeo Posterior Osteosynthesis SystemSpineart · 2013
- Descendant · 2 generations on · 11 of its ownK141835 Romeo Posterior Osteosynthesis System Prebent Cross-Connectors…Spineart · 2014
- Descendant · 3 generations on · 10 of its ownK151695 Romeo posterior osteosynthesis systemSpineart · 2015
- Descendant · cites it directly · 9 of its ownK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
- Descendant · 2 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130267Romeo Posterior Osteosynthesis SystemSpineart · 2013 · cites it directly12descendants
- K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart · 2014 · 2 generations on11descendants
- K151695Romeo posterior osteosynthesis systemSpineart · 2015 · 3 generations on10descendants
- K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017 · cites it directly9descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | Interpore Cross Intl. | 2001 | — |
| −3 | K081165 | Ellipse Lumbar Posterior Osteosynthesis System | Spineart | 2008 | — |
| −2 | K093170 | Romeo Posterior Osteosynthesis System | Spineart | 2009 | — |
| −1 | K101678 | Romeo Posterior Osteosynthesis System | Spineart | 2010 | — |
| 0 (this device) | K112108 | Romeo Posterior Osteosynthesis System | Spineart | 2011 | — |
| +1 | K130267 | Romeo Posterior Osteosynthesis System | Spineart | 2013 | — |
| +2 | K141835 | Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods | Spineart | 2014 | — |
| +3 | K151695 | Romeo posterior osteosynthesis system | Spineart | 2015 | — |
| +1 | K172101 | ROMEO® 2 Posterior Osteosynthesis System | Spineart | 2017 | — |
| +2 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 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 MNI? 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 |
|---|---|---|---|
| * | K081165 | Ellipse Lumbar Posterior Osteosynthesis SystemSummary page 1…esis spinal fixation MNI orthosis, spinal pedicle fixation Device panel ORTHOPEDIC system (K081165) and maretedELLIPSE posterior osteosynthesis system (1(093170 and K Legaly Lregay maretied ROMEO posterior osteo… | 2008 |
| * | K093170 | Romeo Posterior Osteosynthesis SystemSummary page 1…ation Device panel ORTHOPEDIC system (K081165) and maretedELLIPSE posterior osteosynthesis system (1(093170 and K Legaly Lregay maretied ROMEO posterior osteosynthesis devces101678) manufactured by SPINEART pred… | 2009 |
| * | K101678 | Romeo Posterior Osteosynthesis SystemSummary page 1…ystem (K081165) and maretedELLIPSE posterior osteosynthesis system (1(093170 and K Legaly Lregay maretied ROMEO posterior osteosynthesis devces101678) manufactured by SPINEART predcat (1(081165,… | 2010 |
What descends from it? (13)
See all 132 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 10 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130267 (Spineart, 2013) has gone furthest, with 12 descendants of its own.
- 11 other devices also cite its predicate K081165.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
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 L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture…
Read the full statement (136 words)
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 L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO posterior osteosynthesis system is intended for the following indications for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudloarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112108: 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/K112108
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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