510(k) · Cleared
ClearedSustain Radiolucent Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 23, 2004 as substantially equivalent to K031302 (Globus Medical, Inc., 2003) after a 46-day review. Its family tree reaches back 4 generations to 2001. 1 of the 911 devices in its family, counting itself, has a Class I recall. 906 later devices descend from it.
- Decided
- Mar 23, 2004
- Review
- 46 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003275 (2001). 906 later devices descend from it, 10 citing it directly. 1 of the 911 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 3 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 2 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 1 generation backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- This deviceK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
- Descendant · cites it directly · 829 of its ownK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- Descendant · 2 generations on · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- Descendant · 3 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- Descendant · 4 generations on · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
Showing 5 of 906 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 906 · See all- K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005 · cites it directly829descendants
- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · 2 generations on789descendants
- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 3 generations on788descendants
- K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · 3 generations on554descendants
- K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · 4 generations on461descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −3 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −2 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −1 | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| 0 (this device) | K040284 | Sustain Radiolucent Spacer | Globus Medical, Inc. | 2004 | — |
| +1 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| +2 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| +3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| +4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 26 | 0 |
| 2015 | 27 | 0 |
| 2016 | 36 | 0 |
| 2017 | 67 | 0 |
| 2018 | 59 | 0 |
| 2019 | 77 | 0 |
| 2020 | 81 | 0 |
| 2021 | 73 | 1 |
| 2022 | 79 | 0 |
| 2023 | 89 | 0 |
| 2024 | 91 | 0 |
| 2025 | 76 | 0 |
| 2026 | 71 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K031302 | Sustain SpacerSummary page 1…lant, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Globus Sustain Spacer K031302, SE date June 27, 2003 Other legally marketed devices: Synthes Vertebral Spacer K01 1037, SE date July 1, 2002 Medtronic Sofamor… | 2003 |
| † | K011037 | Vertebral Spacer | 2002 |
| † | K031780 | Verte-Stack Spinal System | 2003 |
| † | K031757 | Peek Tetris Spinal Implant | 2003 |
What descends from it? (906)
See all 90610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051205 | Stryker Spine Avs Asl Peek Spacer | 2005 | 829 |
| K072465 | Niko Corpectomy Spacer | 2007 | 327 |
| K060665 | Xpand Radiolucent Corpectomy Spacer | 2006 | 274 |
| K130478 | Sustain and Sustain Radiolucent Spacers | 2013 | 256 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K052670 | Staxx XD System | 2006 | 8 |
| K060916 | Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017. | 2006 | 1 |
| K061380 | Retain Radiolucent Spacer | 2006 | 0 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K051205 (Stryker Spine, 2005) has gone furthest, with 829 descendants of its own.
- 2 other devices also cite its predicate K031302.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Sustain Radiolucent Spacer is a vertebral body replacement device 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 Sustain Radiolucent Spacer is 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…
Read the full statement (110 words)
The Sustain Radiolucent Spacer is a vertebral body replacement device 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 Sustain Radiolucent Spacer is 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.
The Sustain Radiolucent Spacer is 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/K040284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040284: Sustain Radiolucent Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040284
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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