510(k) · Cleared
ClearedSUSTAIN Additional Implants
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 Mar 16, 2016 as substantially equivalent to K130478 (Globus Medical, Inc., 2013) and 5 other predicates after a 271-day review. Its family tree reaches back 17 generations to 1984. 119 later devices descend from it.
- Decided
- Mar 16, 2016
- Review
- 271 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K841189 (1984). 129 ancestors in all. 119 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK151665 SUSTAIN Additional ImplantsGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 55 of its ownK171848 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 37 of its ownK192115 SABLE Expandable SpacerGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 36 of its ownK201087 CORBEL SpacersGlobus Medical, Inc. · 2020
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 6 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 4 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 3 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 2 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 1 generation backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- This deviceK151665 SUSTAIN Additional ImplantsGlobus Medical, Inc. · 2016
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · cites it directly97descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 2 generations on84descendants
- K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc. · 2017 · cites it directly55descendants
- K192115SABLE Expandable SpacerGlobus Medical, Inc. · 2020 · 2 generations on37descendants
- K201087CORBEL SpacersGlobus Medical, Inc. · 2020 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −6 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −4 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −3 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −2 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −1 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| 0 (this device) | K151665 | SUSTAIN Additional Implants | Globus Medical, Inc. | 2016 | — |
| +1 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +2 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
| +1 | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers… | Globus Medical, Inc. | 2017 | — |
| +2 | K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020 | — |
| +3 | K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 18 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 18 | 0 |
| 2024 | 30 | 0 |
| 2025 | 22 | 0 |
| 2026 | 19 | 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.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130478 | Sustain and Sustain Radiolucent SpacersSummary page 4…0 Intervertebral Body Fusion Device Product Codes: MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: SUSTAIN® Spacers (K130478) Additional CALIBER® Spacer (K102293 & K123231) Predicates: Medtronic Capstone Control (K120368)… | 2013 |
| * | K102293 | Caliber SpacerSummary page 4…Product Codes: MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: SUSTAIN® Spacers (K130478) Additional CALIBER® Spacer (K102293 & K123231) Predicates: Medtronic Capstone Control (K120368) NuVasive CoRoent (K100043)… | 2011 |
| * | K123231 | Caliber SpacersSummary page 4…roduct Codes: MAX Regulatory Class: II, Panel Code: 87 Primary Predicate: SUSTAIN® Spacers (K130478) Additional CALIBER® Spacer (K102293 & K123231) Predicates: Medtronic Capstone Control (K120368) NuVasive CoRoent (K100043) Stry… | 2013 |
| * | K120368 | Capstone Control Spinal SystemSummary page 4…I, Panel Code: 87 Primary Predicate: SUSTAIN® Spacers (K130478) Additional CALIBER® Spacer (K102293 & K123231) Predicates: Medtronic Capstone Control (K120368) NuVasive CoRoent (K100043) Stryker AVS PL PEEK Spacers (K143163) Purpose: The purpose o… | 2012 |
| * | K100043 | Coroent XLR Standalone SystemSummary page 4…Spacers (K130478) Additional CALIBER® Spacer (K102293 & K123231) Predicates: Medtronic Capstone Control (K120368) NuVasive CoRoent (K100043) Stryker AVS PL PEEK Spacers (K143163) Purpose: The purpose of this submission is to request clearance for S… | 2010 |
| * | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Summary page 4…02293 & K123231) Predicates: Medtronic Capstone Control (K120368) NuVasive CoRoent (K100043) Stryker AVS PL PEEK Spacers (K143163) Purpose: The purpose of this submission is to request clearance for SUSTAIN® Additional Implants (SUSTAIN®-IR Spacers) and to u… | 2015 |
What descends from it? (119)
See all 1193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 32 years and passes through 12 companies; a new generation was cleared every 11 months on median.
- 14 of the 129 ancestors have a recall of any class.
- Of its descendants, K181357 (Globus Medical, Inc., 2018) has gone furthest, with 97 descendants of its own.
- 11 other devices also cite its predicate K130478.
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. 2016, 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 lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) 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 (118 words)
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN®-IR) 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). 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151665: SUSTAIN Additional Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151665
Report an extraction error
Are you the manufacturer?
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