510(k) Report

510(k) · Cleared

Cleared

Lanx Cervical SA

K112388510(k) TraditionalCleared Dec 16, 2011120-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

Lanx, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

Cleared on Dec 16, 2011 as substantially equivalent to K083389 (Globus Medical, Inc., 2009) and 1 other predicate after a 120-day review. Its family tree reaches back 13 generations to 2001. 26 later devices descend from it.

Decided
Dec 16, 2011
Review
120 days
Class
Class II
Product code
OVE
Recalls
None
Predicates
2

Its longest line of descent runs back 13 generations to K003155 (2001). 33 ancestors in all, the oldest K792352 (1979). 26 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2006: 2 other ancestors2001: 3 other ancestors2005: 1 other ancestor2004: 5 other ancestors2003: 2 other ancestors1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2000: 1 other ancestor1984: 1 other ancestor2014: 1 descendant cleared2016: 2 descendants cleared2021: 3 descendants cleared2018: 1 descendant cleared2022: 3 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2024: 3 descendants cleared2025: 5 descendants cleared2026: 5 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×3: 3 generations cleared close together, K040536 (2004), K041556 (2004), K043561 (2004) ×3: 3 generations cleared close together, K060719 (2006), K062133 (2006), K070173 (2007) K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K094042 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 2 other ancestors5 generations back: 4 other ancestors6 generations back: 5 other ancestors7 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 6 descendants5 generations forward: 6 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants K094042 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek · 2010K073285 · Peek Prevail Cervical Interbody Device · Medtronic Sofamor Danek USA, Inc. · 2008K070173 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2007K062133 · Modification to Verte-Stack Spinal System · Medtronic Spinal and Biologics Div · 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 backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  4. 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  5. 1 generation backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
  6. This deviceK112388 Lanx Cervical SALanx, Inc. · 2011
  7. Descendant · cites it directly · 24 of its ownK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
  8. Descendant · 2 generations on · 21 of its ownK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
  9. Descendant · 3 generations on · 19 of its ownK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
  10. Descendant · 3 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
  11. Descendant · 3 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
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 backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 2 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 1 generation backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
  14. This deviceK112388 Lanx Cervical SALanx, Inc. · 2011

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22018: 12020: 12021: 32022: 32023: 22024: 32025: 52026: 5
2014high 5 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 26 · See all
  • K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014 · cites it directly24descendants
  • K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018 · 2 generations on21descendants
  • K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020 · 3 generations on19descendants
  • K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 3 generations on18descendants
  • K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 3 generations on5descendants
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—
−4K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−3K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−2K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−1K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010—
0 (this device)K112388Lanx Cervical SALanx, Inc.2011—
+1K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.2014—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.2018—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.2020—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC2021—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199810
200010
200130
200320
200450
200510
200620
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201810
202010
202130
202230
202320
202430
202550
202650
FIG. 1 — Lineage of K112388, 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 OVE? 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 OVE device

  1. #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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? (2)

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
*K083389Coalition Spacer
Summary page 1
…n or Usual Name Intervertebral Body Fusion Device Classification Name 21 CFR § 888.3080, Orthosis, spinal intervertebral fusion Predicate Devices Globus CoajitionTM (K083389) Medtronic PEEK PREVAILTM (K094042)…
Globus Medical, Inc.2009—
*K094042Peek Prevail Cervical Interbody Device
Summary page 1
…Fusion Device Classification Name 21 CFR § 888.3080, Orthosis, spinal intervertebral fusion Predicate Devices Globus CoajitionTM (K083389) Medtronic PEEK PREVAILTM (K094042) 1CI236 . ' 2-…
Medtronic Sofamor Danek2010—

Also cleared against K083389: 21 other devices →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424
K152622Alta ACDF SystemBiomet Spine20160

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 10 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • None of the 33 ancestors has a recall.
  • Of its descendants, K132894 (Zimmer Spine, Inc., 2014) has gone furthest, with 24 descendants of its own.
  • 21 other devices also cite its predicate K083389.

How does its category compare?

All OVE devices

OVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OVE

10in 2025

2007: 12008: 42009: 12010: 42011: 82012: 72013: 52014: 112015: 122016: 152017: 92018: 72019: 72020: 132021: 102022: 102023: 162024: 62025: 102026 (partial year): 13
2007high 16 (2023) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVE

105in 2025

2008: 131 days median2010: 210 days median2011: 139 days median2012: 125 days median2013: 71 days median2014: 168 days median2015: 113 days median2016: 149 days median2017: 100 days median2018: 105 days median2019: 87 days median2020: 149 days median2021: 93 days median2022: 144 days median2023: 97 days median2024: 56 days median2025: 105 days median2026 (partial year): 66 days median
2007high 210 (2010) · low 56 (2024)2026

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

Recalls per year · OVE

2in 2021

2013: 12014: 12015: 12016: 12017: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

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

Adverse event reports per year · OVE

132in 2025

2010: 22011: 192012: 592013: 2502014: 1502015: 1732016: 1452017: 1342018: 2102019: 1692020: 1622021: 1862022: 2002023: 1482024: 1422025: 132
2007high 250 (2013) · low 0 (2007)2025

MAUDE reports naming product code OVE, 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
20071—00
2008413100
20091—00
2010421002
20118139019
20127125059
20135711250
2014111681150
2015121131173
2016151491145
201791001134
201871050210
20197870169
2020131490162
202110932186
2022101440200
202316970148
20246560142
2025101050132
202613660—

What is it indicated for?

The Lanx Cervical SA System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine (C3-T 1) at one level. DDD is defined as discogenic pain with deg~eneration of the disc confirmed by history and radiographic studics. Thobse Patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Lanx Cervical SA is to be tilled with autogenous bone graft material, and is to be used with titanium alloy screws which accompany the implant.

Indications for use as stated in the FDA summary.

Also cleared against K083389

21 other devices cite the same predicate.

  • K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC · 2021
  • K191477AEON-C Stand Alone SystemHuvexel Co., Ltd. · 2019
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS…Globus Medical, Inc. · 2016
  • K151939COALITION SpacersGlobus Medical, Inc. · 2016
  • K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015

More from Lanx, Inc.

23 FDA decisions under this applicant name. See the company

  • K131547Lanx Fusion SystemLanx, Inc. · 20131 recall
  • K131156Lanx Spinal Fixation SystemLanx, Inc. · 2013
  • K123767Lanx Fusion System- SALanx, Inc. · 20134 recalls
  • K121316Lanx Spinal Fization SystemLanx, Inc. · 2012
  • K122145Lanx Spinal Fixation SystemLanx, Inc. · 20121 recall

Recent decisions in OVE

The OVE category page

  • K263113ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
  • K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd. · 2026
  • K263049SABER-C SystemElevation Spine · 2026
  • K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
  • K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026

https://510kreport.com/device/K112388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112388: Lanx Cervical SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112388

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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