510(k) Report

510(k) · Cleared

Cleared

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers

K181357510(k) TraditionalCleared Dec 6, 2018198-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. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Dec 6, 2018 as substantially equivalent to K072970 (Globus Medical, Inc., 2008) and 12 other predicates after a 198-day review. Its family tree reaches back 20 generations to 1984. 97 later devices descend from it.

Decided
Dec 6, 2018
Review
198 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
13

Its longest line of descent runs back 20 generations to K841189 (1984). 275 ancestors in all, the oldest K792352 (1979). 97 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 2 other ancestors2016: 5 other ancestors2013: 18 other ancestors2012: 15 other ancestors2010: 14 other ancestors2009: 19 other ancestors2008: 35 other ancestors2015: 5 other ancestors2014: 9 other ancestors2011: 16 other ancestors2007: 15 other ancestors2006: 12 other ancestors2004: 27 other ancestors2003: 16 other ancestors2001: 10 other ancestors1999: 2 other ancestors2005: 17 other ancestors2002: 9 other ancestors2000: 2 other ancestors1996: 2 other ancestors1997: 1 other ancestor1993: 1 other ancestor1998: 1 other ancestor1980: 1 other ancestor1979: 1 other ancestor2019: 1 descendant cleared2020: 3 descendants cleared2023: 14 descendants cleared2021: 6 descendants cleared2026: 16 descendants cleared2022: 11 descendants cleared2024: 28 descendants cleared2025: 18 descendants clearedReference device: K131276 · Lateral Synfix · Synthes (USA) Products, LLC · 2014K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007×2: 2 generations cleared close together, K072120 (2007), K073291 (2008) K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K121683 (2012), K123752 (2013) K132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalled×2: 2 generations cleared close together, K141217 (2014), K143163 (2015) ×2: 2 generations cleared close together, K153782 (2016), K161230 (2016) K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 201719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 39 other ancestors3 generations back: 52 other ancestors4 generations back: 75 other ancestors5 generations back: 45 other ancestors6 generations back: 23 other ancestors7 generations back: 8 other ancestors8 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 26 descendants3 generations forward: 34 descendants4 generations forward: 25 descendants5 generations forward: 8 descendants6 generations forward: 2 descendants K170962 · NuVasive® CoRoent® Thoracolumbar System · Nu Vasive, Incorporated · 2017K161230 · NuVasive Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K153782 · NuVasive® Lumbar Interbody Implants · Nu Vasive, Incorporated · 2016K143163 · AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · 2015K141217 · Acculif TL and PL Cage · Stryker Corporation · 2014 · recalledK132505 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013 · recalledK123752 · Acculif TL and PL Cage · Coalign Innovations, Inc. · 2013K121683 · Acculif TL Cage · Coalign Innovations, Inc. · 2012K110543 · Crescent (R) Spinal System Titanium · Medtronic Sofamor Danek USA, Inc. · 2011K094025 · Crescent Spinal System · Medtronic Sofamor Danek · 2010K073291 · Capstone Spinal System · Medtronic Sofamor Danek USA, Inc. · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−20−15−10−50+5
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 16 generations between
  3. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  4. 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  5. 1 generation backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  6. This deviceK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
  7. Descendant · cites it directly · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
  8. Descendant · cites it directly · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
  9. Descendant · 2 generations on · 36 of its ownK201087 CORBEL SpacersGlobus Medical, Inc. · 2020
  10. Descendant · 2 generations on · 35 of its ownK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
  11. Descendant · 2 generations on · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
Show all 20 generations
  1. Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
  11. 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
  12. 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
  13. 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
  14. 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
  15. 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
  16. 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
  17. 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
  18. 3 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  19. 2 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
  20. 1 generation backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
  21. This deviceK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2019: 12020: 32021: 62022: 112023: 142024: 282025: 182026: 16
2019high 28 (2024) · low 1 (2019)2026

Most influential descendants

Showing 5 of 97 · See all
  • K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · cites it directly84descendants
  • K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · cites it directly37descendants
  • K201087CORBEL SpacersGlobus Medical, Inc. · 2020 · 2 generations on36descendants
  • K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc. · 2021 · 2 generations on35descendants
  • K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · 2 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−19K990148Stackable Cage SystemDepuy Motech Acromed1999—
−18K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−17K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−16K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−15K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−14K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−13K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−12K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−11K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008—
−10K094025Crescent Spinal SystemMedtronic Sofamor Danek2010—
−9K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011—
−8K121683Acculif TL CageCoalign Innovations, Inc.2012—
−7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013—
−6K132505Acculif TL and PL CageCoalign Innovations, Inc.20133
−5K141217Acculif TL and PL CageStryker Corporation20143
−4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK…Stryker Corporation2015—
−3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−2K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016—
−1K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017—
0 (this device)K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.2018—
+1K191391HEDRON Lumbar SpacersGlobus Medical, Inc.2019—
+1K192115SABLE Expandable SpacerGlobus Medical, Inc.2020—
+2K201087CORBEL SpacersGlobus Medical, Inc.2020—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers…Globus Medical, Inc.2021—
+2K201671A-Link ZAcuity Surgical Devices, LLC2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
199310
199620
199710
199810
199920
200020
2001100
200290
2003160
2004270
2005170
2006120
2007150
2008350
2009190
2010140
2011160
2012150
2013180
201490
201550
201650
201720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202030
202160
2022110
2023140
2024280
2025180
2026160
FIG. 1 — Lineage of K181357, 1984–2026Source: 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 MAX? 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? (13)

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
*K072970Patriot Spacers
Summary page 5
…Body Fusion Device Product Code(s): MAX, PHM Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K15202…
Globus Medical, Inc.2008—
*K093242Patriot Transcontinental Llif Spacer
Summary page 5
…Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578…
Globus Medical, Inc.2009—
*K102313Patriot Transcontinental M Spacers
Summary page 5
…Regulatory Class: II, Panel Code: 87 Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665…
Globus Medical, Inc.2010—
*K122097Patriot Spacers
Summary page 5
…Code: 87 Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022…
Globus Medical, Inc.2012—
*K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…
Summary page 5
…Primary Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022)…
Globus Medical, Inc.2016—
*K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…
Summary page 5
…Predicate: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022)…
Globus Medical, Inc.2017—
*K161223TransContinental® M Spacers and InterContinental® Plate-Spacers
Summary page 5
…e: PATRIOT® Spacers (Lumbar) (K072970) Additional Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022) CALIB…
Globus Medical, Inc.2016—
*K130478Sustain and Sustain Radiolucent Spacers
Summary page 5
…l Predicates: PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022) CALIBER® Spacers (K123231) NuVasiv…
Globus Medical, Inc.2013—
*K151665SUSTAIN Additional Implants
Summary page 5
…PATRIOT® Spacers (Lumbar) (K093242, K102313, K122097, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022) CALIBER® Spacers (K123231) NuVasive CoRoent Thoracol…
Globus Medical, Inc.2016—
*K123231Caliber Spacers
Summary page 5
…, K143578, K152022, K161223) SUSTAIN® R Spacers (K130478, K143578, K151665, K152022) CALIBER® Spacers (K123231) NuVasive CoRoent Thoracolumbar System (K170962) Stryker Spine AVS Navigation PEEK Spacer…
Globus Medical, Inc.2013—
*K170962NuVasive® CoRoent® Thoracolumbar System
Summary page 5
…(K130478, K143578, K151665, K152022) CALIBER® Spacers (K123231) NuVasive CoRoent Thoracolumbar System (K170962) Stryker Spine AVS Navigation PEEK Spacer (K100865) Medtronic CRESCENT Spinal System (K17…
Nu Vasive, Incorporated2017—
*K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXX
Summary page 5
…CALIBER® Spacers (K123231) NuVasive CoRoent Thoracolumbar System (K170962) Stryker Spine AVS Navigation PEEK Spacer (K100865) Medtronic CRESCENT Spinal System (K171031) Reference Device: DePuy Synthes SYNFIX Lateral (K131276) Purpos…
Stryker Spine2010—
*K171031CRESCENT™ Spinal System
Summary page 5
…asive CoRoent Thoracolumbar System (K170962) Stryker Spine AVS Navigation PEEK Spacer (K100865) Medtronic CRESCENT Spinal System (K171031) Reference Device: DePuy Synthes SYNFIX Lateral (K131276) Purpose: The purpose of this submission is to request clearance for a…
Medtronic Sofamor Danek2017—
†K131276Lateral SynfixSynthes (USA) Products, LLC2014—

Also cleared against K072970: 28 other devices →

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984
K192115SABLE Expandable SpacerGlobus Medical, Inc.202037

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 34 years and passes through 13 companies; a new generation was cleared every 11 months on median.
  • 27 of the 275 ancestors have a recall of any class.
  • Of its descendants, K191391 (Globus Medical, Inc., 2019) has gone furthest, with 84 descendants of its own.
  • 28 other devices also cite its predicate K072970.

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. 2018, 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?

PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity…

Read the full statement (362 words)

PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

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 K072970

28 other devices cite the same predicate.

  • K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK…Solco Biomedical Co., Ltd. · 2019
  • K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
  • K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
  • K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC · 2017
  • K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™…Globus Medical, Inc. · 2017
  • K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. · 20161 recall

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 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/K181357 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181357: PATRIOT® Lumbar Spacers, SUSTAIN® Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181357

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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