510(k) · Cleared
ClearedRomeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods
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 Sep 10, 2014 as substantially equivalent to K081165 (Spineart, 2008) and 4 other predicates after a 65-day review. Its family tree reaches back 6 generations to 2001. 11 later devices descend from it.
- Decided
- Sep 10, 2014
- Review
- 65 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K011437 (2001). 9 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
- 5 generations backK081165 Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008
- 4 generations backK093170 Romeo Posterior Osteosynthesis SystemSpineart · 2009
- 3 generations backK101678 Romeo Posterior Osteosynthesis SystemSpineart · 2010
- 2 generations backK111127 Romeo Posterior Osteosynthesis SystemSpineart · 2011
- 1 generation backK130267 Romeo Posterior Osteosynthesis SystemSpineart · 2013
- This deviceK141835 Romeo Posterior Osteosynthesis System Prebent Cross-Connectors…Spineart · 2014
- Descendant · cites it directly · 10 of its ownK151695 Romeo posterior osteosynthesis systemSpineart · 2015
- Descendant · 2 generations on · 9 of its ownK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
- Descendant · 3 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- Descendant · 3 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- Descendant · 4 generations on · 3 of its ownK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151695Romeo posterior osteosynthesis systemSpineart · 2015 · cites it directly10descendants
- K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017 · 2 generations on9descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 3 generations on7descendants
- K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 3 generations on4descendants
- K203506PERLA® TL posterior osteosynthesis systemSpineart · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | Interpore Cross Intl. | 2001 | — |
| −5 | K081165 | Ellipse Lumbar Posterior Osteosynthesis System | Spineart | 2008 | — |
| −4 | K093170 | Romeo Posterior Osteosynthesis System | Spineart | 2009 | — |
| −3 | K101678 | Romeo Posterior Osteosynthesis System | Spineart | 2010 | — |
| −2 | K111127 | Romeo Posterior Osteosynthesis System | Spineart | 2011 | — |
| −1 | K130267 | Romeo Posterior Osteosynthesis System | Spineart | 2013 | — |
| 0 (this device) | K141835 | Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods | Spineart | 2014 | — |
| +1 | K151695 | Romeo posterior osteosynthesis system | Spineart | 2015 | — |
| +2 | K172101 | ROMEO® 2 Posterior Osteosynthesis System | Spineart | 2017 | — |
| +3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| +3 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
| +4 | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 4…II Product Code MNH, MNI CFR section 888.3070 Device panel ORTHOPEDIC Ellipse posterior osteosynthesis system (K081165), Romeo® Legally marketed posterior osteosynthesis system (K101678, K111127, K130267) predicate devices and TSRH spinal… | 2008 |
| * | K101678 | Romeo Posterior Osteosynthesis SystemSummary page 4…0 Device panel ORTHOPEDIC Ellipse posterior osteosynthesis system (K081165), Romeo® Legally marketed posterior osteosynthesis system (K101678, K111127, K130267) predicate devices and TSRH spinal system - CD horizon X10 Crosslink Plates by Medtro… | 2010 |
| * | K111127 | Romeo Posterior Osteosynthesis SystemSummary page 4…panel ORTHOPEDIC Ellipse posterior osteosynthesis system (K081165), Romeo® Legally marketed posterior osteosynthesis system (K101678, K111127, K130267) predicate devices and TSRH spinal system - CD horizon X10 Crosslink Plates by Medtronic Sofam… | 2011 |
| * | K130267 | Romeo Posterior Osteosynthesis SystemSummary page 4…ORTHOPEDIC Ellipse posterior osteosynthesis system (K081165), Romeo® Legally marketed posterior osteosynthesis system (K101678, K111127, K130267) predicate devices and TSRH spinal system - CD horizon X10 Crosslink Plates by Medtronic Sofamor Danek,… | 2013 |
| * | K032578 | TSRH Spinal SystemSummary page 4…system (K101678, K111127, K130267) predicate devices and TSRH spinal system - CD horizon X10 Crosslink Plates by Medtronic Sofamor Danek, Inc (K032578) Romeo® posterior osteosynthesis system is intended to provide immobilization and sta… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151695 | Romeo posterior osteosynthesis system | 2015 | 10 |
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 13 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K151695 (Spineart, 2015) has gone furthest, with 10 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. 2014, 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 (133 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: 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; pseudoarthrosis; and failed previous fusion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141835: Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141835
Report an extraction error
Are you the manufacturer?
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