510(k) · Cleared

Cleared

Ebi Omega 21 System

K990303510(k) TraditionalCleared Apr 29, 199987-day reviewClass II21 CFR 888.3050

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

Electro-Biology, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Apr 29, 1999 as substantially equivalent to K973683 (Ebi Electro Biology, 1997) after an 87-day review. Its family tree reaches back 1 generation to 1997. 44 later devices descend from it.

Decided: Apr 29, 1999
Review: 87 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K973683 (1997). 44 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK973683 Omega 21 SystemEbi Electro Biology · 1997
This deviceK990303 Ebi Omega 21 SystemElectro-Biology, Inc. · 1999
Descendant · cites it directly · 43 of its ownK014137 Modification to Ebi Omega 21 SystemEbi, L.P. · 2002
Descendant · cites it directly · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
Descendant · 3 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
Descendant · 4 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2002high 9 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 44 · See all

K014137Modification to Ebi Omega 21 SystemEbi, L.P. · 2002 · cites it directly43descendants
K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 3 generations on17descendants
K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 4 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973683	Omega 21 System	Ebi Electro Biology	1997	—
0 (this device)	K990303	Ebi Omega 21 System	Electro-Biology, Inc.	1999	—
+1	K014137	Modification to Ebi Omega 21 System	Ebi, L.P.	2002	—
+1	K131250	Tiger Spine System	Corelink, LLC	2013	—
+2	K133369	Tiger Spine System	Corelink, LLC	2014	—
+3	K153453	Inertia Pedicle Screw and Deformity Correxxion System	Nexxt Spine, LLC	2016	—
+4	K192121	Black Diamond Pedicle Screw System	Osseus Fusion Systems	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2013	1	0
2014	1	0
2015	2	0
2016	2	0
2018	1	0
2019	3	0
2020	3	0
2021	1	0
2022	4	0
2023	7	0
2024	5	0
2025	9	0
2026	2	0

FIG. 1 — Lineage of K990303, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 KWP? 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

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K973683	Omega 21 System Summary page 1 …ds. Intended Use: The EBI Omega 21™ System has not changed the Indications for Use ot fundamental scientific technology of the previously cleared EBI Omega 21™ System (K973683). The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fi…	Ebi Electro Biology	1997	—

Also cleared against K973683: 4 other devices →

What descends from it? (44)

See all 44

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

Number	Device	Applicant	Decided	Descendants
K014137	Modification to Ebi Omega 21 System	Ebi, L.P.	2002	43
K131250	Tiger Spine System	Corelink, LLC	2013	40
K020681	Ebi OMEGA21 Spinal Fixation System	Ebi, L.P.	2002	1
K023204	Modification to Ebi OMEGA21 Spinal Fixation System	Ebi, L.P.	2002	0

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?

Its one ancestor has no recall.
Of its descendants, K014137 (Ebi, L.P., 2002) has gone furthest, with 43 descendants of its own.
4 other devices also cite its predicate K973683.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

What is it indicated for?

The EBI Omega 21™ System és a spinal fixcation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixation system of the noncervical 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…

Read the full statement (313 words)

The EBI Omega 21™ System és a spinal fixcation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixation system of the noncervical 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 fasled previous fusion (psuedarthrosis).

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 antogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and () who are having the device removed afer the development of a solid fusion mass.

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

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodses 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 studses). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous fasled Juston; 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.

https://510kreport.com/device/K990303 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990303: Ebi Omega 21 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990303

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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