510(k) · Cleared
ClearedSUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
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 Apr 13, 2016 as substantially equivalent to K133967 (Aurora Spine, 2014) and 17 other predicates after a 483-day review. Its family tree reaches back 14 generations to 2001. 210 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 483 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 18
Its longest line of descent runs back 14 generations to K003155 (2001). 115 ancestors in all, the oldest K792352 (1979). 210 later devices descend from it, 8 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 1 generation backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- This deviceK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
- Descendant · cites it directly · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 109 of its ownK170157 INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017
- Descendant · cites it directly · 97 of its ownK181357 PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 94 of its ownK173722 PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 84 of its ownK191391 HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK112459 Synthes Zero-PSynthes Spine Co.Lp · 2011
- 1 generation backK131449 Coalition SpacerGlobus Medical, Inc. · 2013
- This deviceK143578 SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer…Globus Medical, Inc. · 2016
Showing 5 of 210 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 210 · See all- K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016 · cites it directly117descendants
- K170157INDEPENDENCE® SpacersGlobus Medical, Inc. · 2017 · cites it directly109descendants
- K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc. · 2018 · cites it directly97descendants
- K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc. · 2018 · cites it directly94descendants
- K191391HEDRON Lumbar SpacersGlobus Medical, Inc. · 2019 · 2 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K112459 | Synthes Zero-P | Synthes Spine Co.Lp | 2011 | — |
| −1 | K131449 | Coalition Spacer | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +1 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016 | — |
| +1 | K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017 | — |
| +1 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018 | — |
| +1 | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | 2018 | — |
| +2 | K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 18 | 0 |
| 2022 | 23 | 0 |
| 2023 | 34 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 26 | 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? (18)
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 |
|---|---|---|---|
| * | K133967 | Interbody Cage SystemSummary page 6…Spacers OVD INDEPENDENCE® TPS Spacer Regulatory Class: II, Panel Code: 87 Primary Predicate: Aurora Spine Interbody Fusion System (K133967) K143578… | 2014 |
| * | K040284 | Sustain Radiolucent SpacerSummary page 7…K143578 Page 2 of 9 Additional SUSTAIN® R Spacers (K040284 & K130478) Predicates: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K12… | 2004 |
| * | K130478 | Sustain and Sustain Radiolucent SpacersSummary page 7…K143578 Page 2 of 9 Additional SUSTAIN® R Spacers (K040284 & K130478) Predicates: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K122097)… | 2013 |
| * | K072991 | Patriot Spacers: Colonial AcdfSummary page 7…Page 2 of 9 Additional SUSTAIN® R Spacers (K040284 & K130478) Predicates: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K122097) PATRIOT® TransContinental® Spacer (K093242… | 2008 |
| * | K072970 | Patriot SpacersSummary page 7…of 9 Additional SUSTAIN® R Spacers (K040284 & K130478) Predicates: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K122097) PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Space… | 2008 |
| * | K122097 | Patriot SpacersSummary page 7…tional SUSTAIN® R Spacers (K040284 & K130478) Predicates: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K122097) PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Spacer (K102313… | 2012 |
| * | K093242 | Patriot Transcontinental Llif SpacerSummary page 7…s: PATRIOT® Spacers (Cervical) (K072991) PATRIOT® Spacers (Lumbar) (K072970 & K122097) PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231)… | 2009 |
| * | K102313 | Patriot Transcontinental M SpacersSummary page 7…PATRIOT® Spacers (Lumbar) (K072970 & K122097) PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449)… | 2010 |
| * | K102293 | Caliber SpacerSummary page 7…7) PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101)… | 2011 |
| * | K123231 | Caliber SpacersSummary page 7…PATRIOT® TransContinental® Spacer (K093242) PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101)… | 2013 |
| * | K083389 | Coalition SpacerSummary page 7…K093242) PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756… | 2009 |
| * | K131449 | Coalition SpacerSummary page 7…PATRIOT® TransContinental® M Spacer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756)… | 2013 |
| * | K082252 | Independence SpacerSummary page 7…cer (K102313) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756) FORTIFY® I-R Corpectomy Spacer (K121107… | 2008 |
| * | K120101 | Independence SpacerSummary page 7…13) CALIBER® Spacer (K102293 & K123231) COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756) FORTIFY® I-R Corpectomy Spacer (K121107)… | 2012 |
| * | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy SpacersSummary page 7…COALITION® Spacer (K083389 & K131449) INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756) FORTIFY® I-R Corpectomy Spacer (K121107) XPand®-R Corpectomy Spacer (K060665)… | 2011 |
| * | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Summary page 7…INDEPENDENCE® Spacer (K082252 & K120101) FORTIFY®-R Corpectomy Spacer (K112756) FORTIFY® I-R Corpectomy Spacer (K121107) XPand®-R Corpectomy Spacer (K060665) NIKO® Corpectomy Spacer (K072465) Purpose: The pur… | 2012 |
| * | K060665 | Xpand Radiolucent Corpectomy SpacerSummary page 7…) FORTIFY®-R Corpectomy Spacer (K112756) FORTIFY® I-R Corpectomy Spacer (K121107) XPand®-R Corpectomy Spacer (K060665) NIKO® Corpectomy Spacer (K072465) Purpose: The purpose of this submission is to request clearance of the fo… | 2006 |
| * | K072465 | Niko Corpectomy SpacerSummary page 7…12756) FORTIFY® I-R Corpectomy Spacer (K121107) XPand®-R Corpectomy Spacer (K060665) NIKO® Corpectomy Spacer (K072465) Purpose: The purpose of this submission is to request clearance of the following titanium plasma spray coated PEEK spacers: SUS… | 2007 |
What descends from it? (210)
See all 2108 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | 2016 | 117 |
| K170157 | INDEPENDENCE® Spacers | 2017 | 109 |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | 2018 | 97 |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | 2018 | 94 |
| K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and… | 2017 | 83 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K171075 | Calix-C Cervical Interbody Spacer | 2017 | 15 |
| K181261 | Curiteva Cervical Interbody Fusion System | 2018 | 4 |
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 15 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 13 of the 115 ancestors have a recall of any class.
- Of its descendants, K161223 (Globus Medical, Inc., 2016) has gone furthest, with 117 descendants of its own.
- 6 other devices also cite its predicate K133967.
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?
SUSTAIN® Spacers When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) 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)…
Read the full statement (1,215 words)
SUSTAIN® Spacers
When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) 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 nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.
When used as cervical intervertebral body fusion devices, SUSTAIN® 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. SUSTAIN® 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 Systems.
When used as vertebral body replacement devices, SUSTAIN® 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 spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
PATRIOT® Lumbar Spacers
PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices 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 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. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
PATRIOT® Cervical Spacers
PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices 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 as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.
CALIBER® Spacers
CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices 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).
CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.
COALITION® Spacers
COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices 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. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants.
INDEPENDENCE® Spacers
INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices 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). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants.
FORTIFY® Corpectomy Spacers
FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices 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). These devices 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 spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
XPand® Corpectomy Spacers
XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices 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). XPand® Corpectomy 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 system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
NIKO® Corpectomy Spacers
NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices 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). NIKO® Corpectomy 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 spacers can be packed with bone grafting material. NIKO® Corpectomy 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/K143578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143578
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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