510(k) Report

510(k) · Cleared

Cleared

Ellipse Lumbar Posterior Osteosynthesis System

K081165510(k) TraditionalCleared Dec 17, 2008237-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 · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Dec 17, 2008 as substantially equivalent to K011437 (Interpore Cross Intl., 2001) and 1 other predicate after a 237-day review. Its family tree reaches back 1 generation to 2001. 19 later devices descend from it.

Decided
Dec 17, 2008
Review
237 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K011437 (2001). 2 ancestors in all. 19 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2010: 2 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2011: 2 descendants cleared2021: 1 descendant cleared2020: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2014: 2 descendants cleared2018: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared2024: 1 descendant clearedK011437 · Synergy 4.0 MM, 4.5 MM VLS Screws · Interpore Cross Intl. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 12 descendants2 generations forward: 5 descendants3 generations forward: 2 descendants K011437 · Synergy 4.0 MM, 4.5 MM VLS Screws · Interpore Cross Intl. · 20010
  1. Root · 1 generation backK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
  2. This deviceK081165 Ellipse Lumbar Posterior Osteosynthesis SystemSpineart · 2008
  3. Descendant · cites it directly · 18 of its ownK093170 Romeo Posterior Osteosynthesis SystemSpineart · 2009
  4. Descendant · cites it directly · 16 of its ownK101678 Romeo Posterior Osteosynthesis SystemSpineart · 2010
  5. Descendant · cites it directly · 13 of its ownK112108 Romeo Posterior Osteosynthesis SystemSpineart · 2011
  6. Descendant · cites it directly · 13 of its ownK111127 Romeo Posterior Osteosynthesis SystemSpineart · 2011
  7. Descendant · cites it directly · 12 of its ownK130267 Romeo Posterior Osteosynthesis SystemSpineart · 2013

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 22013: 12014: 22015: 12017: 12018: 12020: 22021: 12022: 12023: 22024: 12026: 1
2009high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 19 · See all
  • K093170Romeo Posterior Osteosynthesis SystemSpineart · 2009 · cites it directly18descendants
  • K101678Romeo Posterior Osteosynthesis SystemSpineart · 2010 · cites it directly16descendants
  • K112108Romeo Posterior Osteosynthesis SystemSpineart · 2011 · cites it directly13descendants
  • K111127Romeo Posterior Osteosynthesis SystemSpineart · 2011 · cites it directly13descendants
  • K130267Romeo Posterior Osteosynthesis SystemSpineart · 2013 · cites it directly12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011437Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl.2001—
0 (this device)K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart2008—
+1K093170Romeo Posterior Osteosynthesis SystemSpineart2009—
+1K101678Romeo Posterior Osteosynthesis SystemSpineart2010—
+1K112108Romeo Posterior Osteosynthesis SystemSpineart2011—
+1K111127Romeo Posterior Osteosynthesis SystemSpineart2011—
+1K130267Romeo Posterior Osteosynthesis SystemSpineart2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201120
201310
201420
201510
201710
201810
202020
202110
202210
202320
202410
202610
FIG. 1 — Lineage of K081165, 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K011437Synergy 4.0 MM, 4.5 MM VLS Screws
Summary page 1
…Peiescwspnlytm Device classification 21 CFR 888.3070 Product code MNI, MNH, KWP Legally marketed SYNERGY (K011437) and XIA Spinal system (numerous predicate devices 510k including K013823)…
Interpore Cross Intl.2001—
*K013823Xia Spinal System
Summary page 1
…MNI, MNH, KWP Legally marketed SYNERGY (K011437) and XIA Spinal system (numerous predicate devices 510k including K013823) ELLIPSE posterior osteosynthesis system includes pedicul…
Howmedica Osteonics Corp.2001—

Also cleared against K011437: 11 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K093170Romeo Posterior Osteosynthesis SystemSpineart200918
K101678Romeo Posterior Osteosynthesis SystemSpineart201016
K112108Romeo Posterior Osteosynthesis SystemSpineart201113
K111127Romeo Posterior Osteosynthesis SystemSpineart201113
K130267Romeo Posterior Osteosynthesis SystemSpineart201312
K141835Romeo Posterior Osteosynthesis System Prebent Cross-Connectors; Prebent RodsSpineart201411
K151695Romeo posterior osteosynthesis systemSpineart201510
K140948Romeo Posterior Osteosynthesis SystemSpineart201410
K093936Romeo Posterior Osteosynthesis SystemSpineart201010
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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K093170 (Spineart, 2009) has gone furthest, with 18 descendants of its own.
  • 11 other devices also cite its predicate K011437.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

ELLIPSE posterior osteosynthesis system Is Intended to use In the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE Is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed…

Read the full statement (154 words)

ELLIPSE posterior osteosynthesis system Is Intended to use In the non cervical spine. When use as a pedicle screw fixation system, ELLIPSE Is Intended for patients: a) having severe spondylollsthesis (grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; b) who are receiving fusions using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine and d) who are having the device removed after the development of a solid fusion mass.

When use as a pedicle screw fixation system, ELLIPSE is also 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 (Ti- Si): 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 K011437

11 other devices cite the same predicate.

  • K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd. · 2023
  • K201648Sterispine™ PSSafe Orthopaedics · 20201 recall
  • K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
  • K151921Sterispine PSSafe Orthopaedics · 2015
  • K132403Annextm Adjacent Level SystemSpine Wave, Inc. · 2014
  • K132218Perfix Iliac Screw SystemU&I Corporation · 2013

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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K081165 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081165: Ellipse Lumbar Posterior Osteosynthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081165

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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