510(k) Report

510(k) · Cleared

Cleared

Nextgen Altius Oct System

K113593510(k) TraditionalCleared Apr 17, 2012134-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

Biomet Spine (Aka Ebi, LLC) · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Apr 17, 2012 as substantially equivalent to K043229 (Interpore Cross Intl., 2004) and 11 other predicates after a 134-day review. Its family tree reaches back 13 generations to 2001. 102 later devices descend from it.

Decided
Apr 17, 2012
Review
134 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
12

Its longest line of descent runs back 13 generations to K003155 (2001). 97 ancestors in all, the oldest K841189 (1984). 102 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2009: 3 other ancestors2008: 4 other ancestors2004: 21 other ancestors2002: 8 other ancestors2007: 2 other ancestors2006: 4 other ancestors2005: 10 other ancestors2003: 6 other ancestors2001: 7 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 2 other ancestors1997: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2013: 3 descendants cleared2014: 8 descendants cleared2012: 3 descendants cleared2015: 7 descendants cleared2020: 13 descendants cleared2017: 8 descendants cleared2018: 4 descendants cleared2016: 2 descendants cleared2025: 9 descendants cleared2021: 6 descendants cleared2024: 10 descendants cleared2019: 4 descendants cleared2023: 9 descendants cleared2022: 7 descendants cleared2026: 9 descendants clearedK003155 · 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. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 11 other ancestors2 generations back: 17 other ancestors3 generations back: 17 other ancestors4 generations back: 4 other ancestors5 generations back: 5 other ancestors6 generations back: 11 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 17 descendants3 generations forward: 22 descendants4 generations forward: 21 descendants5 generations forward: 15 descendants6 generations forward: 13 descendants7 generations forward: 6 descendants8 generations forward: 2 descendants K110522 · 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. · 2001−10−50+5
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations between
  3. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  4. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  5. 1 generation backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. This deviceK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  7. Descendant · cites it directly · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  8. Descendant · 2 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  9. Descendant · cites it directly · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  10. Descendant · 2 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  11. Descendant · 3 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
Show all 13 generations
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations backK012254 VBROsteotech, Inc. · 2001
  3. 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 4 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 1 generation backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. This deviceK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

2012: 32013: 32014: 82015: 72016: 22017: 82018: 42019: 42020: 132021: 62022: 72023: 92024: 102025: 92026: 9
2012high 13 (2020) · low 2 (2016)2026

Most influential descendants

Showing 5 of 102 · See all
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · cites it directly75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 2 generations on30descendants
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 3 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−12K012254VBROsteotech, Inc.2001—
−11K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−4K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−1K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
0 (this device)K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+1K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+1K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+3K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199950
200070
200170
200280
200360
2004210
2005100
200640
200720
200840
200930
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201330
201480
201570
201620
201780
201840
201940
2020130
202160
202270
202390
2024100
202590
202690
FIG. 1 — Lineage of K113593, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (12)

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
*K043229Modification to Altius Oct System
Summary page 2
…ing. Substantial Equivalence: The subject components in the Nextgen Altius OCT System are substantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & S…
Interpore Cross Intl.2004—
*K033961Altius Oct System
Summary page 2
…tantial Equivalence: The subject components in the Nextgen Altius OCT System are substantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Rec…
Interpore Cross Intl.2004—
*K022048Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate System
Summary page 2
…ivalence: The subject components in the Nextgen Altius OCT System are substantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction…
Interpore Cross Intl.2002—
*K110353Mountaineer Oct Spinal System
Summary page 2
…us OCT System are substantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, &…
Depuy Spine, Inc.2011—
*K103100Mountaineer Oct Spinal System
Summary page 2
…tem are substantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365).…
Depuy Spine, Inc.2010—
*K080828Mountaineer Oct Spinal System
Summary page 2
…bstantially equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextg…
Depuy Spine, Inc.2008—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 2
…equivalent to the current components in the Altius OaT System (K(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OC…
Depuy Spine, Inc.2004—
*K110522Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 2
…(043229, K(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems…
Medtronic Sofamor Danek USA, Inc.2011—
*K082728Vertex Recontruction System, Vertex Select Reconstruction System
Summary page 2
…(033961 & K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respe…
Medtronic Sofamor Danek USA, Inc.2009—
*K090714Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 2
…K(022048), the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to inte…
Medtronic Sofamor Danek2009—
*K083071Vertex Reconstruction System
Summary page 2
…the Depuy Mountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use a…
Medtronic Sofamor Danek20081
*K091365Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 2
…ountaineer OCT Spinal System (K(110353, K(103100, K(080828, & K(042508) and the Vertex Maxo & Select" Reconstruction Systems (1(110522, K(082728, K(090714, 1(083071, & 1(091365). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use and indicatio…
Medtronic Soafamor Danek2009—

Also cleared against K043229: 9 other devices →

What descends from it? (102)

See all 102

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

NumberDeviceApplicantDecidedDescendants
K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)201375
K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201467
K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217
K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)20127
K120998Solstice Cross ConnectorLife Spine20121
K140734Nextgen Altius Oct SystemEbi, LLC20140

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 11 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 6 of the 97 ancestors have a recall of any class.
  • Of its descendants, K123549 (Biomet Spine (Aka Ebi, LLC), 2013) has gone furthest, with 75 descendants of its own.
  • 9 other devices also cite its predicate K043229.

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. 2012, 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 Nexigen Altius OCT System is intended for use with allograft or autograft and indicated for: ODD (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 lotdosis)…

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 Nexigen Altius OCT System is intended for use with allograft or autograft and indicated for: ODD (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 lotdosis); 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 TI-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 K043229

9 other devices cite the same predicate.

  • K140734Nextgen Altius Oct SystemEbi, LLC · 2014
  • K141284Caspian Spinal SystemK2m, Inc. · 2014
  • K133698Synapse SystemSynthes USA Products, LLC · 2014
  • K090343Sentinel Spinal SystemLife Spine · 2009
  • K072729SierraSeaspine, Inc. · 2008
  • K080526Sierra SystemSeaspine, Inc. · 2008

More from Biomet Spine (Aka Ebi, LLC)

13 FDA decisions under this applicant name. See the company

  • K133518Maxan Anterior Cervical Plate SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC) · 2014
  • K132373Biomet Access SystemBiomet Spine (Aka Ebi, LLC) · 2014
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 20141 recall
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013

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/K113593 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113593: Nextgen Altius Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113593

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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