510(k) Report

510(k) · Cleared

Cleared

Romeo Posterior Osteosynthesis System

K111127510(k) SpecialCleared Aug 11, 2011112-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spineart · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Aug 11, 2011 as substantially equivalent to K081165 (Spineart, 2008) and 2 other predicates after a 112-day review. Its family tree reaches back 4 generations to 2001. 13 later devices descend from it.

Decided
Aug 11, 2011
Review
112 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, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2017: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant clearedK011437 · Synergy 4.0 MM, 4.5 MM VLS Screws · Interpore Cross Intl. · 2001K081165 · Ellipse Lumbar Posterior Osteosynthesis System · Spineart · 2008K093170 · Romeo Posterior Osteosynthesis System · Spineart · 2009K101678 · Romeo Posterior Osteosynthesis System · Spineart · 2010200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants K101678 · Romeo Posterior Osteosynthesis System · Spineart · 2010K093170 · Romeo Posterior Osteosynthesis System · Spineart · 2009K081165 · Ellipse Lumbar Posterior Osteosynthesis System · Spineart · 2008K011437 · Synergy 4.0 MM, 4.5 MM VLS Screws · Interpore Cross Intl. · 20010
  1. Root · 4 generations backK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
  2. 3 generations backK081165 Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008
  3. 2 generations backK093170 Romeo Posterior Osteosynthesis SystemSpineart · 2009
  4. 1 generation backK101678 Romeo Posterior Osteosynthesis SystemSpineart · 2010
  5. This deviceK111127 Romeo Posterior Osteosynthesis SystemSpineart · 2011
  6. Descendant · cites it directly · 12 of its ownK130267 Romeo Posterior Osteosynthesis SystemSpineart · 2013
  7. Descendant · cites it directly · 11 of its ownK141835 Romeo Posterior Osteosynthesis System Prebent Cross-Connectors…Spineart · 2014
  8. Descendant · cites it directly · 10 of its ownK151695 Romeo posterior osteosynthesis systemSpineart · 2015
  9. Descendant · cites it directly · 9 of its ownK172101 ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
  10. 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

2013: 12014: 12015: 12017: 12018: 12020: 22021: 12022: 12023: 22024: 12026: 1
2013high 2 (2020) · low 0 (2016)2026

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 · cites it directly11descendants
  • K151695Romeo posterior osteosynthesis systemSpineart · 2015 · cites it directly10descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−4K011437Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl.2001—
−3K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart2008—
−2K093170Romeo Posterior Osteosynthesis SystemSpineart2009—
−1K101678Romeo Posterior Osteosynthesis SystemSpineart2010—
0 (this device)K111127Romeo Posterior Osteosynthesis SystemSpineart2011—
+1K130267Romeo Posterior Osteosynthesis SystemSpineart2013—
+1K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart2014—
+1K151695Romeo posterior osteosynthesis systemSpineart2015—
+1K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart2017—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart20202

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201710
201810
202020
202110
202210
202320
202410
202610
FIG. 1 — Lineage of K111127, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K081165Ellipse Lumbar Posterior Osteosynthesis System
Summary page 1
…on codes KWP Spinal interlaminal fixation orthosis Device panel ORTHOPEDIC Legally marketed ELLIPSE posterior osteosynthesis system (K081165) and devcesROMEO posterior osteosynthesis system (K<093170 and K predcat predcat devces101678)…
Spineart2008—
*K093170Romeo Posterior Osteosynthesis System
Summary page 1
…devces101678) manufactured by SPINEART The modifications to ROMEO posterior osteosynthesis system (1<081165, K093170, K<101678) manufactured by SPINEART consist of addition of * Extension of the…
Spineart2009—
*K101678Romeo Posterior Osteosynthesis System
Summary page 1
…ELLIPSE posterior osteosynthesis system (K081165) and devcesROMEO posterior osteosynthesis system (K<093170 and K predcat predcat devces101678) manufactured by SPINEART The modifications to ROMEO posterior osteosynthesis s…
Spineart2010—

Also cleared against K081165: 11 other devices →

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130267Romeo Posterior Osteosynthesis SystemSpineart201312
K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411
K151695Romeo posterior osteosynthesis systemSpineart201510
K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179

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 1.0 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 devices

MNI 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

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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-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.

Also cleared against K081165

11 other devices cite the same predicate.

  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
  • K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart · 2017
  • K151695Romeo posterior osteosynthesis systemSpineart · 2015
  • K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart · 2014
  • K140948Romeo Posterior Osteosynthesis SystemSpineart · 2014

More from Spineart

44 FDA decisions under this applicant name. See the company

  • K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart · 2023
  • K213470PERLA® TL Posterior Osteosynthesis SystemSpineart · 2022
  • K210472SPINEART Navigation Instrument SystemSpineart · 2021
  • K203506PERLA® TL posterior osteosynthesis systemSpineart · 20212 recalls
  • K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K111127 · printed Nov 4, 2026

Cite this page

510(k) Report. “K111127: Romeo Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111127

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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