510(k) · Cleared
ClearedRetain 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 Jun 8, 2006 as substantially equivalent to K040284 (Globus Medical, Inc., 2004) after a 21-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 8, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003275 (2001). No later device cites it as a predicate yet.
- 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 deviceK061380 Retain Radiolucent SpacerGlobus Medical, Inc. · 2006
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) | K061380 | Retain Radiolucent Spacer | Globus Medical, Inc. | 2006 | — |
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? (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 |
|---|---|---|---|
| * | K040284 | Sustain Radiolucent SpacerSummary page 1…, fixation, spinal intervertebral body fixation orthosis devices. Class II. The Product Code is MQP. The Panel Code is 87. PREDICATE DEVICES: Sustain Radiolucent Spacer K040284, SE date March 23, 2004 DEVICE DESCRIPTION: The Retain Radiolucent Spacer is a vertebral body replacement device used to provide… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 ancestors has a recall of any class.
- 9 other devices also cite its predicate K040284.
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 Retain 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 Retain 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 Retain 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/K061380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061380: Retain Radiolucent Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061380
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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