510(k) · Cleared
ClearedSustain 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 Jun 27, 2003 as substantially equivalent to K003275 (Synthes (Usa), 2001) and 2 other predicates after a 64-day review. Its family tree reaches back 3 generations to 2001. 1 of the 915 devices in its family, counting itself, has a Class I recall. 911 later devices descend from it.
- Decided
- Jun 27, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003275 (2001). 911 later devices descend from it, 3 citing it directly. 1 of the 915 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 2 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 1 generation backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- This deviceK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- Descendant · cites it directly · 906 of its ownK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
- Descendant · 2 generations on · 829 of its ownK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- Descendant · 3 generations on · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- Descendant · 4 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
Showing 5 of 911 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 911 · See all- K040284Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004 · cites it directly906descendants
- K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005 · 2 generations on829descendants
- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · 3 generations on789descendants
- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 4 generations on788descendants
- K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · 4 generations on554descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −2 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −1 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| 0 (this device) | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| +1 | K040284 | Sustain Radiolucent Spacer | Globus Medical, Inc. | 2004 | — |
| +2 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| +3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| +4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 26 | 0 |
| 2015 | 27 | 0 |
| 2016 | 36 | 0 |
| 2017 | 67 | 0 |
| 2018 | 59 | 0 |
| 2019 | 78 | 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? (3)
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 |
|---|---|---|---|
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 2…, 2000 was presented. BASIS OF SUBSTANTIAL EQUIVALENCE: The Sustain Spacer implants are similar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) and Synthes Vertebral Spacer Ti vertebral body replacement device(s) (KO20125 and K024364) with respect to technical characteris… | 2001 |
| * | K020152 | Synthes Vertebral Spacer TI | 2002 |
| * | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow)Summary page 2…imilar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) and Synthes Vertebral Spacer Ti vertebral body replacement device(s) (KO20125 and K024364) with respect to technical characteristics and performance. 4 DEPA… | 2003 |
What descends from it? (911)
See all 9113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K040284 (Globus Medical, Inc., 2004) has gone furthest, with 906 descendants of its own.
- 12 other devices also cite its predicate K003275.
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 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 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 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/K031302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031302: Sustain Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031302
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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