510(k) · Cleared
ClearedSynthes Vertebral Spacer TI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · MQP Spinal Vertebral Body Replacement Device
Cleared on Apr 16, 2002 as substantially equivalent to K003275 (Synthes (Usa), 2001) after an 89-day review. Its family tree reaches back 1 generation to 2001. 1 of the 1,686 devices in its family, counting itself, has a Class I recall. 1,684 later devices descend from it.
- Decided
- Apr 16, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003275 (2001). 1,684 later devices descend from it, 5 citing it directly. 1 of the 1,686 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- This deviceK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- Descendant · cites it directly · 1,683 of its ownK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- Descendant · 2 generations on · 1,621 of its ownK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- Descendant · 3 generations on · 1,620 of its ownK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- Descendant · 4 generations on · 1,571 of its ownK043206 Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005
- Descendant · 4 generations on · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
Showing 5 of 1,684 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 1,684 · See all- K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003 · cites it directly1,683descendants
- K040482Ebi Esl Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,621descendants
- K042268Ebi Cas Spine Spacer SystemEbi, L.P. · 2004 · 3 generations on1,620descendants
- K043206Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer)Pioneer Surgical Technology · 2005 · 4 generations on1,571descendants
- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · 4 generations on1,440descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| 0 (this device) | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| +1 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| +2 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| +3 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| +4 | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) | Pioneer Surgical Technology | 2005 | — |
| +4 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 10 | 0 |
| 2006 | 11 | 0 |
| 2007 | 10 | 0 |
| 2008 | 21 | 0 |
| 2009 | 14 | 0 |
| 2010 | 23 | 0 |
| 2011 | 48 | 0 |
| 2012 | 56 | 0 |
| 2013 | 66 | 0 |
| 2014 | 91 | 0 |
| 2015 | 86 | 0 |
| 2016 | 101 | 0 |
| 2017 | 127 | 0 |
| 2018 | 117 | 0 |
| 2019 | 118 | 0 |
| 2020 | 107 | 0 |
| 2021 | 106 | 1 |
| 2022 | 107 | 0 |
| 2023 | 139 | 0 |
| 2024 | 126 | 0 |
| 2025 | 101 | 0 |
| 2026 | 91 | 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 |
|---|---|---|---|
| * | K003275 | Synthes Synmesh Spacer SystemSummary page 1…ion, spinal intervertebral body fixation orthosis devices. Class . Product code is MQP. The Panel code is 87. Vertebral body replacement device: Synthes SynMesh System: K003275 SE date: April 23, 2001. The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supple… | 2001 |
What descends from it? (1,684)
See all 1,6845 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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Vertebral Spacer Tiis 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 Vertebral Spacer T7 is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone.
The Vertebral Spacer Tiis designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020152: Synthes Vertebral Spacer TI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020152
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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