510(k) Report

510(k) · Cleared

Cleared

ALTA Anterior Cervical Interbody Spacer

K160154510(k) TraditionalCleared May 13, 2016114-day reviewClass II21 CFR 888.3080

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

Astura Medical · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on May 13, 2016 as substantially equivalent to K073351 (Spinal Elements, Inc., 2008) and 3 other predicates after a 114-day review. Its family tree reaches back 13 generations to 2001. 63 later devices descend from it.

Decided
May 13, 2016
Review
114 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
4

Its longest line of descent runs back 13 generations to K003155 (2001). 64 ancestors in all, the oldest K841189 (1984). 63 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 2 other ancestors2008: 6 other ancestors2001: 8 other ancestors2005: 5 other ancestors2002: 5 other ancestors2004: 11 other ancestors1999: 2 other ancestors1996: 1 other ancestor2007: 4 other ancestors2003: 5 other ancestors2000: 1 other ancestor1984: 1 other ancestor2018: 1 descendant cleared2019: 4 descendants cleared2017: 1 descendant cleared2023: 14 descendants cleared2020: 7 descendants cleared2021: 5 descendants cleared2024: 12 descendants cleared2025: 9 descendants cleared2022: 3 descendants cleared2026: 7 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×2: 2 generations cleared close together, K021791 (2002), K023570 (2002) K031780 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004×2: 2 generations cleared close together, K042571 (2005), K050624 (2005) K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 2009K100889 · Endoskeleton TC · Titan Spine, LLC · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 9 other ancestors4 generations back: 14 other ancestors5 generations back: 12 other ancestors6 generations back: 5 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 13 descendants3 generations forward: 18 descendants4 generations forward: 11 descendants5 generations forward: 7 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants K100889 · Endoskeleton TC · Titan Spine, LLC · 2010K083311 · Aesculap Cespace Peek Intervertebral Body Fusion System · Aesculap Implant Systems, Inc. · 2009K071983 · Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space · Aesculap Implant Systems, Inc. · 2008 · recalledK060762 · Aesculap Peek Vertebral Body Replacement System · Aesculap, Inc. · 2006K051205 · Stryker Spine Avs Asl Peek Spacer · Stryker Spine · 2005K050624 · Stryker Spine Avs PL Peek Spacer · Stryker Spine · 2005K042571 · Stryker Spine Avs TL Peek Spacer · Stryker Spine · 2005K040731 · Stryker Spine Vertebral Spacer · Stryker Spine · 2004K031780 · 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 backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  4. 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  5. 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
  6. This deviceK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016
  7. Descendant · cites it directly · 31 of its ownK163481 HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017
  8. Descendant · cites it directly · 27 of its ownK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
  9. Descendant · 2 generations on · 21 of its ownK182877 HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
  10. Descendant · 2 generations on · 15 of its ownK182477 Cervical SpacerAdditive Implants, LLC · 2019
  11. Descendant · 2 generations on · 14 of its ownK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
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 backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
  7. 7 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
  8. 6 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
  9. 5 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
  10. 4 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
  11. 3 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
  12. 2 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
  13. 1 generation backK100889 Endoskeleton TCTitan Spine, LLC · 2010
  14. This deviceK160154 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2016

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 42020: 72021: 52022: 32023: 142024: 122025: 92026: 7
2017high 14 (2023) · low 1 (2017)2026

Most influential descendants

Showing 5 of 63 · See all
  • K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical · 2017 · cites it directly31descendants
  • K173324ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018 · cites it directly27descendants
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019 · 2 generations on21descendants
  • K182477Cervical SpacerAdditive Implants, LLC · 2019 · 2 generations on15descendants
  • K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020 · 2 generations on14descendants
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—
−9K031780Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040731Stryker Spine Vertebral SpacerStryker Spine2004—
−7K042571Stryker Spine Avs TL Peek SpacerStryker Spine2005—
−6K050624Stryker Spine Avs PL Peek SpacerStryker Spine2005—
−5K051205Stryker Spine Avs Asl Peek SpacerStryker Spine2005—
−4K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006—
−3K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace…Aesculap Implant Systems, Inc.20081
−2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009—
−1K100889Endoskeleton TCTitan Spine, LLC2010—
0 (this device)K160154ALTA Anterior Cervical Interbody SpacerAstura Medical2016—
+1K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical2017—
+1K173324ALTA Anterior Cervical Interbody SpacerAstura Medical2018—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC2019—
+2K182477Cervical SpacerAdditive Implants, LLC2019—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199920
200010
200180
200250
200350
2004110
200550
200740
200860
200920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201940
202070
202150
202230
2023140
2024120
202590
202670
FIG. 1 — Lineage of K160154, 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 ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ODP device

  1. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K073351Crystal
Summary page 4
…ction 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Spinal Elements, Crystal Cervical Cage (K073351) Device Titan, Endoskeleton® TC (K100889) Additional Predicate Zimmer, BAK/C Vista Interbody Fu…
Spinal Elements, Inc.2008—
*K100889Endoskeleton TC
Summary page 4
…Orthopedic Primary Predicate Spinal Elements, Crystal Cervical Cage (K073351) Device Titan, Endoskeleton® TC (K100889) Additional Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Inter…
Titan Spine, LLC2010—
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 4
…ts, Crystal Cervical Cage (K073351) Device Titan, Endoskeleton® TC (K100889) Additional Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Interbody Fusion System (K091088) Titan Spine Endosk…
Sulzer Spine-Tech2001—
*K091088LDR Spine Cervical Interbody Fusion System
Summary page 4
…keleton® TC (K100889) Additional Predicate Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Devices LDR Spine Cervical Interbody Fusion System (K091088) Titan Spine Endoskeleton TC (K100889) The ALTA Cervical Interbody Spacer…
Ldr Spine USA2009—

Also cleared against K073351: 26 other devices →

What descends from it? (63)

See all 63

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

NumberDeviceApplicantDecidedDescendants
K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731
K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827
K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203
K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193
K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230

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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 5 of the 64 ancestors have a recall of any class.
  • Of its descendants, K163481 (Astura Medical, 2017) has gone furthest, with 31 descendants of its own.
  • 26 other devices also cite its predicate K073351.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

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

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

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 K073351

26 other devices cite the same predicate.

  • K191812ADI Cervical Interbody Fusion DeviceAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019
  • K173148ACIFColigne AG · 2017
  • K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC · 2017
  • K170297Tranquil Interbody SystemNexus Spine, LLC · 2017
  • K143479Bluefin Interbody SystemTides Medical · 2015
  • K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI…Osteomed Implantes, Ltda · 2015

More from Astura Medical

21 FDA decisions under this applicant name. See the company

  • K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2026
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K240160EGPS Navigated InstrumentsAstura Medical · 2024
  • K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024

Recent decisions in ODP

The ODP category page

  • K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc. · 2026
  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K2530413d Cage CervicalFims Co., Ltd. · 2026
  • K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero®…Stryker Spine · 2026
  • K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC · 2026

https://510kreport.com/device/K160154 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160154: ALTA Anterior Cervical Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160154

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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