510(k) Report

510(k) · Cleared

Cleared

ELEVATE Spinal System

K142559510(k) TraditionalCleared Jun 9, 2015271-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

Medtronic Sofamor Danek USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Jun 9, 2015 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 8 other predicates after a 271-day review. Its family tree reaches back 15 generations to 2001. 1 of the 262 devices in its family, counting itself, has a Class I recall. 130 later devices descend from it.

Decided
Jun 9, 2015
Review
271 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
9

Its longest line of descent runs back 15 generations to K003155 (2001). 131 ancestors in all, the oldest K792352 (1979). 130 later devices descend from it, 7 citing it directly. 1 of the 262 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 5 other ancestors2011: 8 other ancestors2010: 5 other ancestors2009: 10 other ancestors2008: 17 other ancestors2007: 9 other ancestors2005: 6 other ancestors2003: 11 other ancestors1999: 3 other ancestors1996: 2 other ancestors2006: 3 other ancestors2004: 16 other ancestors2002: 6 other ancestors2001: 9 other ancestors2000: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2017: 2 descendants cleared2020: 6 descendants cleared2022: 10 descendants cleared2024: 31 descendants cleared2021: 7 descendants cleared, 1 with a Class I recall12019: 3 descendants cleared2023: 13 descendants cleared2025: 28 descendants cleared2026: 30 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. · 2008K100214 · Cornerstone PSR Cervical Interbody Fusion Device · Medtronic Sofamor Danek · 2010K111264 · Cornerstone (R) PSR Cervical Fusion System · Medtronic Sofamor Danek USA · 2011K122037 · Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst · Medtronic Sofamor Danek, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 22 other ancestors3 generations back: 19 other ancestors4 generations back: 33 other ancestors5 generations back: 18 other ancestors6 generations back: 13 other ancestors7 generations back: 2 other ancestors8 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 12 descendants3 generations forward: 22 descendants, 1 with a Class I recall14 generations forward: 29 descendants5 generations forward: 36 descendants6 generations forward: 18 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants K122037 · Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail Cervical Interbody Device Capst · Medtronic Sofamor Danek, Inc. · 2013K111264 · Cornerstone (R) PSR Cervical Fusion System · Medtronic Sofamor Danek USA · 2011K100214 · Cornerstone PSR Cervical Interbody Fusion 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. · 2001−15−10−50+5
  1. Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations between
  3. 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  4. 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  5. 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  6. This deviceK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
  7. Descendant · cites it directly · 103 of its ownK163581 Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017
  8. Descendant · cites it directly · 79 of its ownK201267 Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  9. Descendant · cites it directly · 56 of its ownK210425 Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · Recalled
  10. Descendant · 2 generations on · 55 of its ownK212524 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021
  11. Descendant · 3 generations on · 49 of its ownK214010 Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022
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 backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
  11. 5 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
  12. 4 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
  13. 3 generations backK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
  14. 2 generations backK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
  15. 1 generation backK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
  16. This deviceK142559 ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2017: 22019: 32020: 62021: 72022: 102023: 132024: 312025: 282026: 30
2017high 31 (2024) · low 0 (2018)2026

Class I recalls in this family

  • K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 130 · See all
  • K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly103descendants
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020 · cites it directly79descendants
  • K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2021 · cites it directly56descendants
  • K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc. · 2021 · 2 generations on55descendants
  • K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA · 2022 · 3 generations on49descendants
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—
−6K062133Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div2006—
−5K070173Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2007—
−4K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008—
−3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010—
−2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011—
−1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System…Medtronic Sofamor Danek, Inc.2013—
0 (this device)K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015—
+1K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017—
+1K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek2020—
+1K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20211
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.2021—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198410
199620
199810
199930
200010
200190
200260
2003110
2004160
200560
200630
200790
2008170
2009100
201050
201180
201250
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201930
202060
202171
2022100
2023130
2024310
2025280
2026300
FIG. 1 — Lineage of K142559, 2001–2026Source: 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.

1 device in this family has a Class I recall. 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 MAX device

  1. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (9)

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
*K102293Caliber Spacer
Summary page 4
…Class: II Product Code: MAX III. Predicate Devices: Globus CALIBER® K102293(Primary) (S.E. January 5th, 2011) CAPSTONE…
Globus Medical, Inc.2011—
*K073291Capstone Spinal System
Summary page 4
…Globus CALIBER® K102293(Primary) (S.E. January 5th, 2011) CAPSTONE® Spinal System K073291 & K123027 (S.E. April 24th, 2008 & July 25th, 2013)…
Medtronic Sofamor Danek USA, Inc.2008—
*K123027Capstone (R) Spinal System
Summary page 4
…LIBER® K102293(Primary) (S.E. January 5th, 2011) CAPSTONE® Spinal System K073291 & K123027 (S.E. April 24th, 2008 & July 25th, 2013) C…
Medtronic Sofamor Danek, Inc.2013—
*K094025Crescent Spinal System
Summary page 4
…K073291 & K123027 (S.E. April 24th, 2008 & July 25th, 2013) CRESCENT® Spinal System K094025 (S.E. April 26th, 2010) Globus PATRIOT® K07…
Medtronic Sofamor Danek2010—
*K072970Patriot Spacers
Summary page 4
…CRESCENT® Spinal System K094025 (S.E. April 26th, 2010) Globus PATRIOT® K072970 (S.E. January 18th, 2008) SOVEREIGN® Spinal…
Globus Medical, Inc.2008—
*K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…
Summary page 4
…Globus PATRIOT® K072970 (S.E. January 18th, 2008) SOVEREIGN® Spinal System K122037 (S.E March 22nd, 2013)…
Medtronic Sofamor Danek, Inc.2013—
*K113447Rise Spacer
Summary page 5
…K142559 Page 2 of 5 Globus RISE® Spacer K113447 (S.E. January 26, 2012) WAVE™ D Cage K083626 &…
Globus Medical, Inc.2012—
*K083626Distractable Wave Cage
Summary page 5
…Globus RISE® Spacer K113447 (S.E. January 26, 2012) WAVE™ D Cage K083626 & K121333 (S.E. October 17, 2009 & S.E. June 29, 2012)…
Advanced Medical Technology, Inc.2009—
*K121333Wave D Cage
Summary page 5
…Globus RISE® Spacer K113447 (S.E. January 26, 2012) WAVE™ D Cage K083626 & K121333 (S.E. October 17, 2009 & S.E. June 29, 2012) The predic…
Advanced Medical Technologies AG2012—

Also cleared against K102293: 30 other devices →

What descends from it? (130)

See all 130

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

NumberDeviceApplicantDecidedDescendants
K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103
K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079
K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202156
K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176
K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204
K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240
K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
  • 10 of the 131 ancestors have a recall of any class.
  • Of its descendants, K163581 (Medtronic Sofamor Danek USA, Inc., 2017) has gone furthest, with 103 descendants of its own.
  • 30 other devices also cite its predicate K102293.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

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

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, 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
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients…

Read the full statement (131 words)

The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K102293

30 other devices cite the same predicate.

  • K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc. · 2023
  • K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated · 2021
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  • K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
  • K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC · 2019
  • K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K142559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142559: ELEVATE Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142559

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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