510(k) Report

510(k) · Cleared

Cleared

Ebi OMEGA21 Spinal Fixation System

K031354510(k) TraditionalCleared Aug 6, 200399-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

Ebi, L.P. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Aug 6, 2003 as substantially equivalent to K013887 (Spinal Concepts, Inc., 2002) and 2 other predicates after a 99-day review. Its family tree reaches back 1 generation to 1997. 13 later devices descend from it.

Decided
Aug 6, 2003
Review
99 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K964159 (1997). 3 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor2009: 2 descendants cleared2008: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2020: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant clearedK964159 · CD Spinal System · Sofamor Danek USA,Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K964159 · CD Spinal System · Sofamor Danek USA,Inc. · 19970+5
  1. Root · 1 generation backK964159 CD Spinal SystemSofamor Danek USA,Inc. · 1997
  2. This deviceK031354 Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2003
  3. Descendant · cites it directly · 11 of its ownK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
  4. Descendant · cites it directly · 11 of its ownK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
  5. Descendant · 2 generations on · 10 of its ownK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
  6. Descendant · 2 generations on · 9 of its ownK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
  7. Descendant · 2 generations on · 8 of its ownK151215 Mercury Spinal SystemSpinal Elements, Inc. · 2015

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22014: 12015: 12018: 12019: 12020: 22022: 12025: 22026: 1
2008high 2 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 13 · See all
  • K082353Mercury Spinal SystemSpinal Elements, Inc. · 2009 · cites it directly11descendants
  • K083230Mercury Spinal SystemSpinal Elements, Inc. · 2008 · cites it directly11descendants
  • K091587Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 2 generations on10descendants
  • K141372Mercury Spinal SystemSpinal Elements, Inc. · 2014 · 2 generations on9descendants
  • K151215Mercury Spinal SystemSpinal Elements, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964159CD Spinal SystemSofamor Danek USA,Inc.1997—
0 (this device)K031354Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.2003—
+1K082353Mercury Spinal SystemSpinal Elements, Inc.2009—
+1K083230Mercury Spinal SystemSpinal Elements, Inc.2008—
+2K091587Mercury Spinal SystemSpinal Elements, Inc.2009—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.2014—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201410
201510
201810
201910
202020
202210
202520
202610
FIG. 1 — Lineage of K031354, 1997–2026Source: 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
*K013887Bacfix Spinal Fixation System
Summary page 1
…erlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: e Spinal Concepts BacFix Spinal Fixation System (K013887) e Sofamor Danek CD Spinal System (K964159) e Sofamor Danek Townley Pedicle Screw Plating System (K9837…
Spinal Concepts, Inc.2002—
*K964159CD Spinal System
Summary page 1
…rketed devices that are substantially equivalent: e Spinal Concepts BacFix Spinal Fixation System (K013887) e Sofamor Danek CD Spinal System (K964159) e Sofamor Danek Townley Pedicle Screw Plating System (K983706) 4. Description of the device: The EBI@Omega2 1 Spi…
Sofamor Danek USA,Inc.1997—
*K983706Modification of Townley Pedicle Screw Plating System
Summary page 1
…ncepts BacFix Spinal Fixation System (K013887) e Sofamor Danek CD Spinal System (K964159) e Sofamor Danek Townley Pedicle Screw Plating System (K983706) 4. Description of the device: The EBI@Omega2 1 Spinal Fixation System is a spinal fixation device that utilizes rods, screw…
Sofamor Danek USA,Inc.1998—

Also cleared against K013887: 2 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K082353Mercury Spinal SystemSpinal Elements, Inc.200911
K083230Mercury Spinal SystemSpinal Elements, Inc.200811

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 3 ancestors has a recall.
  • Of its descendants, K082353 (Spinal Elements, Inc., 2009) has gone furthest, with 11 descendants of its own.
  • 2 other devices also cite its predicate K013887.

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.

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?

The EBI Omega2 1 Spinal Fixation System is a non-celvical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraYiliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with…

Read the full statement (101 words)

The EBI Omega2 1 Spinal Fixation System is a non-celvical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraYiliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by hstory and rahographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K013887

2 other devices cite the same predicate.

  • K031355Ebi Spinelink - II Spinal Fixation SystemEbi, L.P. · 2003
  • K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc. · 2003

More from Ebi, L.P.

101 FDA decisions under this applicant name. See the company

  • K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010
  • K100220Polaris Spinal SystemEbi, L.P. · 2010
  • K093880Peanut Growth Control Plating SystemEbi, L.P. · 20101 recall
  • K092574Esl Spinal SystemEbi, L.P. · 2010
  • K093057Biomet Vision Footring SystemEbi, L.P. · 2009

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/K031354 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031354: Ebi OMEGA21 Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031354

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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