510(k) Report

510(k) · Cleared

Cleared

Independence Spacer

K120101510(k) SpecialCleared Mar 27, 201275-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 Mar 27, 2012 as substantially equivalent to K082252 (Globus Medical, Inc., 2008) and 1 other predicate after a 75-day review. Its family tree reaches back 11 generations to 1984. 224 later devices descend from it.

Decided
Mar 27, 2012
Review
75 days
Class
Class II
Product code
OVD
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K841189 (1984). 21 ancestors in all. 224 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 3 other ancestors2007: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor2016: 4 descendants cleared2021: 20 descendants cleared2019: 8 descendants cleared2013: 1 descendant cleared2017: 6 descendants cleared2015: 1 descendant cleared2023: 36 descendants cleared2022: 24 descendants cleared2018: 5 descendants cleared2020: 14 descendants cleared2025: 38 descendants cleared2024: 41 descendants cleared2026: 26 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. · 2009K103382 · Intercontinental Plate-Spacer · Globus Medical, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 3 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 27 descendants3 generations forward: 53 descendants4 generations forward: 71 descendants5 generations forward: 39 descendants6 generations forward: 18 descendants7 generations forward: 6 descendants8 generations forward: 1 descendant K103382 · Intercontinental Plate-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 · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  4. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  5. 1 generation backK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
  6. This deviceK120101 Independence SpacerGlobus Medical, Inc. · 2012
  7. Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
  8. Descendant · cites it directly · 175 of its ownK142498 MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015
  9. Descendant · cites it directly · 166 of its ownK132559 Monument SpacersGlobus Medical, Inc. · 2013
  10. Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
  11. Descendant · 2 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
  5. 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
  6. 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
  7. 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
  8. 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
  9. 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
  10. 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
  11. 1 generation backK103382 Intercontinental Plate-SpacerGlobus Medical, Inc. · 2011
  12. This deviceK120101 Independence SpacerGlobus Medical, Inc. · 2012

Showing 5 of 224 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12016: 42017: 62018: 52019: 82020: 142021: 202022: 242023: 362024: 412025: 382026: 26
2013high 41 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 224 · See all
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
  • K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015 · cites it directly175descendants
  • K132559Monument SpacersGlobus Medical, Inc. · 2013 · cites it directly166descendants
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
  • K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · 2 generations on117descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K020522Modification to Surgical Titanium Mesh SystemDepuyacromed2002—
−7K030833Depuy Acromed VBR SystemDepuyacromed2003—
−6K031635Depuy Acromed VBR SystemDepuyacromed2003—
−5K041722Modification to VBR Spinal SystemDepuy Spine, Inc.2004—
−4K052746Concorde VBR Spinal SystemDepuy Spine, Inc.2005—
−3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009—
−2K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009—
−1K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011—
0 (this device)K120101Independence SpacerGlobus Medical, Inc.2012—
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS…Globus Medical, Inc.2016—
+1K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015—
+1K132559Monument SpacersGlobus Medical, Inc.2013—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers…Globus Medical, Inc.2017—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200120
200310
200720
200830

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201640
201760
201850
201980
2020140
2021200
2022240
2023360
2024410
2025380
2026260
FIG. 1 — Lineage of K120101, 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? (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
*K082252Independence Spacer
Summary page 1
…§888.3080 Intervertebral Body Fusion Device Product Code: OVID Regulatory Class 11,Panel Code: 87 Predicate(s): INDEPENDENCE® Spacer (K082252) InterContinental®D Plate-Spacer (K1 03382) Purpose: The purpose of this submission is to request clearance for…
Globus Medical, Inc.2008—
*K103382Intercontinental Plate-Spacer
Summary page 1
…Product Code: OVID Regulatory Class 11,Panel Code: 87 Predicate(s): INDEPENDENCE® Spacer (K082252) InterContinental®D Plate-Spacer (K1 03382) Purpose: The purpose of this submission is to request clearance for hydroxyapatite coated (HA) screws, for use with the cleared…
Globus Medical, Inc.2011—

Also cleared against K082252: 12 other devices →

What descends from it? (224)

See all 224

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

NumberDeviceApplicantDecidedDescendants
K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210
K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175
K132559Monument SpacersGlobus Medical, Inc.2013166
K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149
K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111
K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109
K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135
K181118Reliance Lumbar IBF SystemReliance Medical Systems20190
K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160

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 28 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
  • None of the 21 ancestors has a recall.
  • Of its descendants, K143578 (Globus Medical, Inc., 2016) has gone furthest, with 210 descendants of its own.
  • 12 other devices also cite its predicate K082252.

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. 2012, 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 INDEPENDENCE® 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 INDEPENDENCE Spacer is to be filled with autogenous bone graft material and is to be used with three titanium alloy screws, which accompany the implant.

Indications for use as stated in the FDA summary.

Also cleared against K082252

12 other devices cite the same predicate.

  • K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA…Globus Medical, Inc. · 2021
  • K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc. · 2016
  • K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS…Globus Medical, Inc. · 2016
  • K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc. · 2015

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

  • K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium…INNO Holdings Inc. DBA Innovasis · 2026
  • K261408SABER-XA SystemElevation Spine · 2026
  • 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/K120101 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120101: Independence Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120101

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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