510(k) Report

510(k) · Cleared

Cleared

Modification to Ebi OMEGA21 Spinal Fixation System

K023204510(k) SpecialCleared Oct 18, 200223-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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Oct 18, 2002 as substantially equivalent to K020681 (Ebi, L.P., 2002) and 6 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1997.

Decided
Oct 18, 2002
Review
23 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K973683 (1997). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1999: 2 other ancestorsK973683 · Omega 21 System · Ebi Electro Biology · 1997K990303 · Ebi Omega 21 System · Electro-Biology, Inc. · 1999K014137 · Modification to Ebi Omega 21 System · Ebi, L.P. · 2002K020681 · Ebi OMEGA21 Spinal Fixation System · Ebi, L.P. · 200219961998200020022004
Other ancestors, by generation 1 generation back: 3 other ancestors K020681 · Ebi OMEGA21 Spinal Fixation System · Ebi, L.P. · 2002K014137 · Modification to Ebi Omega 21 System · Ebi, L.P. · 2002K990303 · Ebi Omega 21 System · Electro-Biology, Inc. · 1999K973683 · Omega 21 System · Ebi Electro Biology · 19970
  1. Root · 4 generations backK973683 Omega 21 SystemEbi Electro Biology · 1997
  2. 3 generations backK990303 Ebi Omega 21 SystemElectro-Biology, Inc. · 1999
  3. 2 generations backK014137 Modification to Ebi Omega 21 SystemEbi, L.P. · 2002
  4. 1 generation backK020681 Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002
  5. This deviceK023204 Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K973683Omega 21 SystemEbi Electro Biology1997—
−3K990303Ebi Omega 21 SystemElectro-Biology, Inc.1999—
−2K014137Modification to Ebi Omega 21 SystemEbi, L.P.2002—
−1K020681Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.2002—
0 (this device)K023204Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200010
FIG. 1 — Lineage of K023204, 1997–2002Source: 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.

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  • 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? (7)

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
*K020681Ebi OMEGA21 Spinal Fixation System
Summary page 1
…Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal…
Ebi, L.P.2002—
*K014137Modification to Ebi Omega 21 System
Summary page 1
…Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal Fixation…
Ebi, L.P.2002—
*K001357Modification to Omega 21 SystemEbi, L.P.2000—
*K992333Ebi Omega 21 System
Summary page 1
…erlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal Fixation System is a spinal…
Electro-Biology, Inc.1999—
*K991721Ebi Omega 21 System
Summary page 1
…osis 3. Predicate or legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal Fixation System is a spinal fixation device tha…
Ebi Electro Biology1999—
*K990303Ebi Omega 21 System
Summary page 1
…Predicate or legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal Fixation System is a spinal fixation device that utilize…
Electro-Biology, Inc.1999—
*K973683Omega 21 System
Summary page 1
…legally marketed devices that are substantially equivalent: e EBI@Omega 21TMSystem (K020681, K014137, KOO1357, K992333, K991721, K990303, and K973683). 4. Description of the device: The EBI@Omega21 Spinal Fixation System is a spinal fixation device that utilizes rods, screw…
Ebi Electro Biology1997—

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • None of the 7 ancestors has a recall.

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.

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?

The EBI@Omega2ITM Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic…

Read the full statement (314 words)

The EBI@Omega2ITM Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - SI) 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

Indications for use as stated in the FDA summary.

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 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/K023204 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023204: Modification to 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/K023204

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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