510(k) Report

510(k) · Cleared

Cleared

Ebi OMEGA21 Spinal Fixation System

K020681510(k) SpecialCleared Apr 3, 200230-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 Apr 3, 2002 as substantially equivalent to K014137 (Ebi, L.P., 2002) and 5 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.

Decided
Apr 3, 2002
Review
30 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K973683 (1997). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 2 other ancestors2002: 1 descendant clearedK973683 · Omega 21 System · Ebi Electro Biology · 1997K990303 · Ebi Omega 21 System · Electro-Biology, Inc. · 1999K014137 · Modification to Ebi Omega 21 System · Ebi, L.P. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K014137 · 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 · 3 generations backK973683 Omega 21 SystemEbi Electro Biology · 1997
  2. 2 generations backK990303 Ebi Omega 21 SystemElectro-Biology, Inc. · 1999
  3. 1 generation backK014137 Modification to Ebi Omega 21 SystemEbi, L.P. · 2002
  4. This deviceK020681 Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002
  5. Descendant · cites it directly · 0 of its ownK023204 Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K023204Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K020681, 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.

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? (6)

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
*K014137Modification to Ebi Omega 21 System
Summary page 1
…al Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is…
Ebi, L.P.2002—
*K001357Modification to Omega 21 System
Summary page 1
…ixation Orthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is a spinal…
Ebi, L.P.2000—
*K992333Ebi Omega 21 System
Summary page 1
…rthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is a spinal fix%ttio:…
Electro-Biology, Inc.1999—
*K991721Ebi Omega 21 System
Summary page 1
…Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is a spinal fix%ttio:n device…
Ebi Electro Biology1999—
*K990303Ebi Omega 21 System
Summary page 1
…terlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is a spinal fix%ttio:n device that util…
Electro-Biology, Inc.1999—
*K973683Omega 21 System
Summary page 1
…xation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: * - EBI® Omega 21™ System (K014137, K001357, K992333, K991721, K990303, and K973683). 4. Def%cr.iptif:oni of the device: The EBI® Omega21 Spinal Fixation System is a spinal fix%ttio:n device that utilizes rods, sc…
Ebi Electro Biology1997—

Also cleared against K014137: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023204Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.20020

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 6 ancestors has a recall.
  • Of its descendants, K023204 (Ebi, L.P., 2002) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K014137.

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® Omega21™ 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 (315 words)

The EBI® Omega21™ 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 — 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 (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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K014137

2 other devices cite the same predicate.

  • K131250Tiger Spine SystemCorelink, LLC · 2013
  • K023204Modification to Ebi OMEGA21 Spinal Fixation SystemEbi, L.P. · 2002

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/K020681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020681: 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/K020681

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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