510(k) Report

510(k) · Cleared

Cleared

MAGNIFY and MAGNIFY-S Spacers

K142498510(k) TraditionalCleared Feb 26, 2015174-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

Globus Medical, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

Cleared on Feb 26, 2015 as substantially equivalent to K102293 (Globus Medical, Inc., 2011) and 5 other predicates after a 174-day review. Its family tree reaches back 13 generations to 1984. 175 later devices descend from it.

Decided
Feb 26, 2015
Review
174 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
6

Its longest line of descent runs back 13 generations to K841189 (1984). 28 ancestors in all. 175 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 1 other ancestor2008: 4 other ancestors2011: 1 other ancestor2010: 1 other ancestor2007: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor2023: 29 descendants cleared2021: 13 descendants cleared2017: 5 descendants cleared2022: 19 descendants cleared2018: 2 descendants cleared2020: 10 descendants cleared2019: 5 descendants cleared2025: 33 descendants cleared2024: 36 descendants cleared2026: 23 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002×2: 2 generations cleared close together, K030833 (2003), K031635 (2003) K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K102293 · Caliber Spacer · Globus Medical, Inc. · 2011K113447 · Rise Spacer · Globus Medical, Inc. · 2012K122097 · Patriot Spacers · Globus Medical, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 20 descendants3 generations forward: 42 descendants4 generations forward: 58 descendants5 generations forward: 34 descendants6 generations forward: 10 descendants7 generations forward: 3 descendants K122097 · Patriot Spacers · Globus Medical, Inc. · 2012K113447 · Rise Spacer · Globus Medical, Inc. · 2012K102293 · Caliber Spacer · Globus Medical, Inc. · 2011K093242 · Patriot Transcontinental Llif Spacer · Globus Medical, Inc. · 2009K090899 · Depuy Spine Lateral System · Depuy Spine, Inc. · 2009K052746 · Concorde VBR Spinal System · Depuy Spine, Inc. · 2005K041722 · Modification to VBR Spinal System · Depuy Spine, Inc. · 2004K031635 · Depuy Acromed VBR System · Depuyacromed · 2003K030833 · Depuy Acromed VBR System · Depuyacromed · 2003K020522 · Modification to Surgical Titanium Mesh System · Depuyacromed · 2002K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations between
  3. 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
  4. 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
  5. 1 generation backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
  6. This deviceK142498 MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015
  7. Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
  8. Descendant · cites it directly · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
  9. Descendant · 2 generations on · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
  10. Descendant · 2 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  11. Descendant · 2 generations on · 83 of its ownK173115 COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS®…Globus Medical, Inc. · 2017
Show all 13 generations
  1. Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 10 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 5 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  10. 4 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  11. 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
  12. 2 generations backK113447 Rise SpacerGlobus Medical, Inc. · 2012
  13. 1 generation backK122097 Patriot SpacersGlobus Medical, Inc. · 2012
  14. This deviceK142498 MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015

Showing 5 of 175 descendants. See all descendants

Descendants cleared per year

2017: 52018: 22019: 52020: 102021: 132022: 192023: 292024: 362025: 332026: 23
2017high 36 (2024) · low 2 (2018)2026

Most influential descendants

Showing 5 of 175 · See all
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · cites it directly109descendants
  • K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · 2 generations on97descendants
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 2 generations on84descendants
  • K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc. · 2017 · 2 generations on83descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−12K990148Stackable Cage SystemDepuy Motech Acromed1999—
−11K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−10K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−9K030833Depuy Acromed VBR SystemDepuyacromed2003—
−8K031635Depuy Acromed VBR SystemDepuyacromed2003—
−7K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−6K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−5K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009—
−4K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009—
−3K102293Caliber SpacerGlobus Medical, Inc.2011—
−2K113447Rise SpacerGlobus Medical, Inc.2012—
−1K122097Patriot SpacersGlobus Medical, Inc.2012—
0 (this device)K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—
+1K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.2018—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.2019—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS…Globus Medical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200310
200720
200840
201010
201110
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201750
201820
201950
2020100
2021130
2022190
2023290
2024360
2025330
2026230
FIG. 1 — Lineage of K142498, 1984–2026Source: 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 OVD? 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 OVD device

  1. #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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? (6)

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
…tervertebral Body Fusion Device Product Codes: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231)…
Globus Medical, Inc.2011—
*K082252Independence Spacer
Summary page 4
…Product Codes: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231) PATRIOT® Continental® (K072970 & K122097) Purpose:…
Globus Medical, Inc.2008—
*K120101Independence Spacer
Summary page 4
…des: OVD, MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231) PATRIOT® Continental® (K072970 & K122097) Purpose: The purpos…
Globus Medical, Inc.2012—
*K123231Caliber Spacers
Summary page 4
…lass: II, Panel Code: 87 Primary Predicate: CALIBER® Spacer (K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231) PATRIOT® Continental® (K072970 & K122097) Purpose: The purpose of this submission is to request clearance f…
Globus Medical, Inc.2013—
*K072970Patriot Spacers
Summary page 4
…® Spacer (K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231) PATRIOT® Continental® (K072970 & K122097) Purpose: The purpose of this submission is to request clearance for the MAGNIFY™ Spacers. Device Description: MAGNIF…
Globus Medical, Inc.2008—
*K122097Patriot Spacers
Summary page 4
…K102293) Additional INDEPENDENCE® Spacer (K082252 & K120101) Predicates: CALIBER® Spacer (K123231) PATRIOT® Continental® (K072970 & K122097) Purpose: The purpose of this submission is to request clearance for the MAGNIFY™ Spacers. Device Description: MAGNIFY™ Spacers…
Globus Medical, Inc.2012—

Also cleared against K102293: 30 other devices →

What descends from it? (175)

See all 175

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

NumberDeviceApplicantDecidedDescendants
K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149
K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109
K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755
K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135
K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232
K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222
K211740DualXAmplify Surgical, Inc.20211
K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., 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 31 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 28 ancestors has a recall of any class.
  • Of its descendants, K152022 (Globus Medical, Inc., 2017) has gone furthest, with 149 descendants of its own.
  • 30 other devices also cite its predicate K102293.

How does its category compare?

All OVD devices

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

FDA decisions per year · OVD

10in 2025

2007: 22008: 82009: 32010: 82011: 92012: 102013: 112014: 142015: 122016: 132017: 122018: 142019: 122020: 142021: 72022: 142023: 122024: 122025: 102026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVD

100in 2025

2008: 84 days median2009: 152 days median2010: 117 days median2011: 167 days median2012: 78 days median2013: 137 days median2014: 139 days median2015: 166 days median2016: 127 days median2017: 127 days median2018: 126 days median2019: 91 days median2020: 91 days median2021: 108 days median2022: 133 days median2023: 92 days median2024: 110 days median2025: 100 days median2026 (partial year): 93 days median
2007high 167 (2011) · low 78 (2012)2026

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

Recalls per year · OVD

1in 2025

2013: 42016: 12021: 12022: 12025: 12026 (partial year): 1
2007high 4 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OVD

50in 2025

2009: 22010: 22011: 62012: 162013: 172014: 352015: 432016: 552017: 722018: 1122019: 1712020: 2032021: 2212022: 742023: 672024: 922025: 50
2007high 221 (2021) · low 0 (2007)2025

MAUDE reports naming product code OVD, 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
20072—00
200888400
2009315202
2010811702
2011916706
20121078016
201311137417
201414139035
201512166043
201613127155
201712127072
2018141260112
201912910171
202014910203
202171081221
202214133174
20231292067
202412110092
202510100150
20268931—

What is it indicated for?

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1…

Read the full statement (218 words)

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-§ Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

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 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 Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in OVD

The OVD category page

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  • K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026
  • K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc. · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026

https://510kreport.com/device/K142498 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142498: MAGNIFY and MAGNIFY-S Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142498

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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