510(k) Report

510(k) · Cleared

Cleared

Nextgen Altius Oct System

K140734510(k) TraditionalCleared Dec 15, 2014266-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

Ebi, LLC · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 15, 2014 as substantially equivalent to K122378 (Biomet Spine (Aka Ebi, LLC), 2012) and 5 other predicates after a 266-day review. Its family tree reaches back 15 generations to 2001.

Decided
Dec 15, 2014
Review
266 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
6

Its longest line of descent runs back 15 generations to K003155 (2001). 109 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 3 other ancestors2007: 3 other ancestors2004: 22 other ancestors2010: 3 other ancestors2009: 4 other ancestors2008: 4 other ancestors2005: 12 other ancestors2003: 7 other ancestors2002: 8 other ancestors2001: 7 other ancestors2006: 4 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 2 other ancestors1997: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestorK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K122378 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012 · recalled19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 22 other ancestors3 generations back: 22 other ancestors4 generations back: 11 other ancestors5 generations back: 6 other ancestors6 generations back: 11 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor K122378 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012 · recalledK113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations between
  3. 3 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  4. 2 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  5. 1 generation backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
  6. This deviceK140734 Nextgen Altius Oct SystemEbi, LLC · 2014
Show all 15 generations
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 14 generations backK012254 VBROsteotech, Inc. · 2001
  3. 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 6 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 5 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 4 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 3 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 2 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 1 generation backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
  16. This deviceK140734 Nextgen Altius Oct SystemEbi, LLC · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−14K012254VBROsteotech, Inc.2001—
−13K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−10K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−6K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−5K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−4K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−1K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)20121
0 (this device)K140734Nextgen Altius Oct SystemEbi, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199950
200070
200170
200280
200370
2004220
2005120
200640
200730
200840
200940
201030
201130
FIG. 1 — Lineage of K140734, 2001–2014Source: 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 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? (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
*K122378Nextgen Altius Oct System
Summary page 5
…ubject components being added to the Nextgen Altius OCT System are substantially equivalent to the current components in the primary predicate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System…
Biomet Spine (Aka Ebi, LLC)20121
*K113593Nextgen Altius Oct System
Summary page 5
…lly equivalent to the current components in the primary predicate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K11343…
Biomet Spine (Aka Ebi, LLC)2012—
*K043229Modification to Altius Oct System
Summary page 5
…nt to the current components in the primary predicate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K07190…
Interpore Cross Intl.2004—
*K110522Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 5
…ate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K071905). The Nextgen Altius OCT System is substantially…
Medtronic Sofamor Danek USA, Inc.2011—
*K113434Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)
Summary page 5
…predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K071905). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use a…
Lanx, Inc.2011—
*K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)
Summary page 5
…Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K071905). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use and indicatio…
Lanx, LLC2007—

Also cleared against K122378: 3 other devices →

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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 9 of the 109 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K122378.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
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

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis)…

Read the full statement (168 words)

When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only.

They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system’s package insert for a list of indications for use for each system.

Indications for use as stated in the FDA summary.

Also cleared against K122378

3 other devices cite the same predicate.

  • K162575Z-LINKPC SystemZavation, LLC · 2017
  • K141284Caspian Spinal SystemK2m, Inc. · 2014
  • K131833Centurion Poct SystemOrthofix, Inc. · 2014

More from Ebi, LLC

4 FDA decisions under this applicant name. See the company

  • K140123Polaris Spinal System -Translation ScrewEbi, LLC · 20141 recall
  • K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 20121 recall
  • K111376Construx External Fixation DeviceEbi, LLC · 20111 recall

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K140734 · printed Nov 5, 2026

Cite this page

510(k) Report. “K140734: Nextgen Altius Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140734

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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