510(k) · Cleared
ClearedSustain and Sustain Radiolucent Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 26, 2013 as substantially equivalent to K072970 (Globus Medical, Inc., 2008) and 7 other predicates after a 151-day review. Its family tree reaches back 11 generations to 1984. 1 of the 286 devices in its family, counting itself, has a Class I recall. 256 later devices descend from it.
- Decided
- Jul 26, 2013
- Review
- 151 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K841189 (1984). 29 ancestors in all. 256 later devices descend from it, 12 citing it directly. 1 of the 286 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK130478 Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 210 of its ownK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · cites it directly · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · cites it directly · 119 of its ownK151665 SUSTAIN Additional ImplantsGlobus Medical, Inc. · 2016
- Descendant · 2 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK130478 Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc. · 2013
Showing 5 of 256 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub2 generations on · 2021
Most influential descendants
Showing 5 of 256 · See all- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
- K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · cites it directly155descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
- K151665SUSTAIN Additional ImplantsGlobus Medical, Inc. · 2016 · cites it directly119descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K130478 | Sustain and Sustain Radiolucent Spacers | Globus Medical, Inc. | 2013 | — |
| +1 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +1 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +1 | K151665 | SUSTAIN Additional Implants | Globus Medical, Inc. | 2016 | — |
| +2 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 18 | 0 |
| 2021 | 23 | 1 |
| 2022 | 24 | 0 |
| 2023 | 35 | 0 |
| 2024 | 46 | 0 |
| 2025 | 42 | 0 |
| 2026 | 31 | 0 |
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 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072970 | Patriot SpacersSummary page 1…sion device Product Codes MQP, MAX, and ODP. Regulatory Class 11,Panel Code 87. Predicate(s): PATRIOT® Spacers (Lumbar) K072970 PATRIOT® Spacers (Cervical) K072991 PATRIOT® Transcontinenta TM Spacers (Lumbar) K09324… | 2008 |
| * | K072991 | Patriot Spacers: Colonial AcdfSummary page 1…and ODP. Regulatory Class 11,Panel Code 87. Predicate(s): PATRIOT® Spacers (Lumbar) K072970 PATRIOT® Spacers (Cervical) K072991 PATRIOT® Transcontinenta TM Spacers (Lumbar) K093242 CALIBER TM Spacers (Lumbar) K10229… | 2008 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 1…e(s): PATRIOT® Spacers (Lumbar) K072970 PATRIOT® Spacers (Cervical) K072991 PATRIOT® Transcontinenta TM Spacers (Lumbar) K093242 CALIBER TM Spacers (Lumbar) K102293 SUSTAIN® Spacers K031302 SUSTA… | 2009 |
| * | K102293 | Caliber SpacerSummary page 1…PATRIOT® Spacers (Cervical) K072991 PATRIOT® Transcontinenta TM Spacers (Lumbar) K093242 CALIBER TM Spacers (Lumbar) K102293 SUSTAIN® Spacers K031302 SUSTAIN® Radiolucent Spacers K040284 COAL… | 2011 |
| * | K031302 | Sustain SpacerSummary page 1…PATRIOT® Transcontinenta TM Spacers (Lumbar) K093242 CALIBER TM Spacers (Lumbar) K102293 SUSTAIN® Spacers K031302 SUSTAIN® Radiolucent Spacers K040284 COALITION® Spacers K083389 BA… | 2003 |
| * | K040284 | Sustain Radiolucent SpacerSummary page 1…(Lumbar) K093242 CALIBER TM Spacers (Lumbar) K102293 SUSTAIN® Spacers K031302 SUSTAIN® Radiolucent Spacers K040284 COALITION® Spacers K083389 BAK/Cervical (BAK-C®) Interbody Fusion System P980048 Purpos… | 2004 |
| * | K083389 | Coalition SpacerSummary page 1…Spacers (Lumbar) K102293 SUSTAIN® Spacers K031302 SUSTAIN® Radiolucent Spacers K040284 COALITION® Spacers K083389 BAK/Cervical (BAK-C®) Interbody Fusion System P980048 Purpose: The purpose of this submission is to add inte… | 2009 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…SUSTAIN® Radiolucent Spacers K040284 COALITION® Spacers K083389 BAK/Cervical (BAK-C®) Interbody Fusion System P980048 Purpose: The purpose of this submission is to add intervertebral indications for SUSTAIN® and SUSTAIN® R Spacers and to make ster… | 2001 |
What descends from it? (256)
See all 25612 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | 2015 | 155 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K151665 | SUSTAIN Additional Implants | 2016 | 119 |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | 2018 | 97 |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | 2018 | 94 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | 2019 | 42 |
| K180909 | REVEL Spacers | 2018 | 37 |
| K131350 | Calix Lumbar Spinal Implant System | 2013 | 21 |
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 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K143578 (Globus Medical, Inc., 2016) has gone furthest, with 210 descendants of its own.
- 28 other devices also cite its predicate K072970.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are 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…
Read the full statement (343 words)
When used as a lumbar intervertebral body fusion device, SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are 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 SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE™ or BEACON® Stabilization Systems.
When used as a cervical intervertebral body fusion device, the SUSTAIN® and SUSTAIN® R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic 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) weeks of non-operative treatment. The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate System.
When used as a vertebral body replacement device, SUSTAIN® and SUSTAIN® R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130478 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130478: Sustain and Sustain Radiolucent Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130478
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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