510(k) · Cleared
ClearedXpand Radiolucent Corpectomy 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 May 10, 2006 as substantially equivalent to K050850 (Globus Medical, Inc., 2005) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 2001. 274 later devices descend from it.
- Decided
- May 10, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003275 (2001). 6 ancestors in all. 274 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 4 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 3 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 2 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- 1 generation backK040284 Sustain Radiolucent SpacerGlobus Medical, Inc. · 2004
- This deviceK060665 Xpand Radiolucent Corpectomy SpacerGlobus Medical, Inc. · 2006
- Descendant · cites it directly · 268 of its ownK112756 Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011
- Descendant · 2 generations on · 214 of its ownK121107 Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012
- 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 · 149 of its ownK152022 SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE®…Globus Medical, Inc. · 2017
- Descendant · 2 generations on · 117 of its ownK161223 TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc. · 2016
Showing 5 of 274 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 274 · See all- K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc. · 2011 · cites it directly268descendants
- K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc. · 2012 · 2 generations on214descendants
- K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc. · 2016 · cites it directly210descendants
- K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc. · 2017 · cites it directly149descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −4 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −3 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −2 | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| −1 | K040284 | Sustain Radiolucent Spacer | Globus Medical, Inc. | 2004 | — |
| 0 (this device) | K060665 | Xpand Radiolucent Corpectomy Spacer | Globus Medical, Inc. | 2006 | — |
| +1 | K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | Globus Medical, Inc. | 2011 | — |
| +2 | K121107 | Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) | Globus Medical, Inc. | 2012 | — |
| +1 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… | Globus Medical, Inc. | 2016 | — |
| +1 | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… | Globus Medical, Inc. | 2017 | — |
| +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 |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 14 | 0 |
| 2020 | 19 | 0 |
| 2021 | 18 | 0 |
| 2022 | 26 | 0 |
| 2023 | 40 | 0 |
| 2024 | 49 | 0 |
| 2025 | 45 | 0 |
| 2026 | 37 | 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 MQP? 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? (2)
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 |
|---|---|---|---|
| * | K050850 | Xpand Corpectomy SpacerSummary page 1…ixation, spinal intervertebral body fixation orthosis devices. Class II.The Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Globus XPand Corpectomy Spacer K050850, SE date May 26, 2005 Globus Sustain Radiolucent Spacer K040284, SE date March 23, 2004 DEVICE DESCRIPTION: The XPand Radiolucent… | 2005 |
| * | K040284 | Sustain Radiolucent SpacerSummary page 1…lass II.The Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Globus XPand Corpectomy Spacer K050850, SE date May 26, 2005 Globus Sustain Radiolucent Spacer K040284, SE date March 23, 2004 DEVICE DESCRIPTION: The XPand Radiolucent Corpectomy Spacer device is a vertebral body replacement device… | 2004 |
What descends from it? (274)
See all 2745 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | 2011 | 268 |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers… | 2016 | 210 |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 | 149 |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 | 55 |
| K111294 | Santorini Spinal System | 2012 | 18 |
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 5 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K112756 (Globus Medical, Inc., 2011) has gone furthest, with 268 descendants of its own.
- 4 other devices also cite its predicate K050850.
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 XPand Radiolucent Corpectomy 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 XPand Radiolucent Corpectomy 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…
Read the full statement (113 words)
The XPand Radiolucent Corpectomy 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 XPand Radiolucent Corpectomy 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 XPand Radiolucent Corpectomy 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/K060665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060665: Xpand Radiolucent 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/K060665
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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