510(k) Report

510(k) · Cleared

Cleared

Modification to Altius Oct System

K043229510(k) SpecialCleared Dec 21, 200429-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

Interpore Cross Intl. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 21, 2004 after a 29-day review. The FDA summary names no predicate by number. 142 later devices descend from it.

Decided
Dec 21, 2004
Review
29 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

142 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2012: 6 descendants cleared2008: 2 descendants cleared2014: 11 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2007: 2 descendants cleared2011: 3 descendants cleared2023: 12 descendants cleared2020: 15 descendants cleared2017: 9 descendants cleared2015: 13 descendants cleared2013: 5 descendants cleared2018: 7 descendants cleared2010: 2 descendants cleared2016: 4 descendants cleared2022: 8 descendants cleared2025: 9 descendants cleared2021: 7 descendants cleared2024: 10 descendants cleared2019: 5 descendants cleared2026: 9 descendants cleared200020052010201520202025
  1. This deviceK043229 Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  2. Descendant · cites it directly · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  3. Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  4. Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  5. Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  6. Descendant · 3 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014

Showing 5 of 142 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 22010: 22011: 32012: 62013: 52014: 112015: 132016: 42017: 92018: 72019: 52020: 152021: 72022: 82023: 122024: 102025: 92026: 9
2006high 15 (2020) · low 1 (2006)2026

Most influential descendants

Showing 5 of 142 · See all
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly102descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043229Modification to Altius Oct SystemInterpore Cross Intl.2004—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200920
201020
201130
201260
201350
2014110
2015130
201640
201790
201870
201950
2020150
202170
202280
2023120
2024100
202590
202690
FIG. 1 — Lineage of K043229, 2004–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (142)

See all 142

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

NumberDeviceApplicantDecidedDescendants
K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102
K090343Sentinel Spinal SystemLife Spine200921
K062934SierraSeaspine, Inc.200621
K080526Sierra SystemSeaspine, Inc.20089
K133698Synapse SystemSynthes USA Products, LLC20146
K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC20076
K072729SierraSeaspine, Inc.20085
K061943Anatomica Posterior Cervical Fixation SystemAnatomica AB20072
K140734Nextgen Altius Oct SystemEbi, LLC20140
K141284Caspian Spinal SystemK2m, Inc.20140

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?

  • Of its descendants, K113593 (Biomet Spine (Aka Ebi, LLC), 2012) has gone furthest, with 102 descendants of its own.

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

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 to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International Altius OCT System is indicated for:

* DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

* Spondyloslisthesis

* Spinal stenosis

* Fracture/dislocation

* Atlantoaxial fracture with instability

* Occipitocervical dislocation

* Revision of previous cervical spine surgery

* Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

Indications for use as stated in the FDA summary.

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004
  • K040928Expandable Peek VBR ImplantInterpore Cross Intl. · 2004

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/K043229 · printed Nov 3, 2026

Cite this page

510(k) Report. “K043229: Modification to Altius Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043229

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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