510(k) · Cleared
Recalled · Class III · 2020Synthes Synmesh Spacer System
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 23, 2001 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 1,706 devices in its family, counting itself, has a Class I recall. 1,705 later devices descend from it. It has been recalled 14 times.
- Decided
- Apr 23, 2001
- Review
- 186 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 14
- Predicates
- 0
1,705 later devices descend from it, 13 citing it directly. 1 of the 1,706 devices in this family, counting this one, has a Class I recall.
- This deviceK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001
- Descendant · cites it directly · 1,684 of its ownK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- Descendant · 2 generations on · 1,683 of its ownK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- Descendant · cites it directly · 1,622 of its ownK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- Descendant · 2 generations on · 1,621 of its ownK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- Descendant · 2 generations on · 1,620 of its ownK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
Showing 5 of 1,705 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 1,705 · See all- K020152Synthes Vertebral Spacer TISynthes (Usa) · 2002 · cites it directly1,684descendants
- K024364Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003 · 2 generations on1,683descendants
- K020887Ebi Ais Spine SystemEbi, L.P. · 2002 · cites it directly1,622descendants
- K040482Ebi Esl Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,621descendants
- K042268Ebi Cas Spine Spacer SystemEbi, L.P. · 2004 · 2 generations on1,620descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | — |
| +1 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| +2 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| +1 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| +2 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| +2 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 13 | 0 |
| 2006 | 12 | 0 |
| 2007 | 12 | 0 |
| 2008 | 22 | 0 |
| 2009 | 14 | 0 |
| 2010 | 23 | 0 |
| 2011 | 49 | 0 |
| 2012 | 56 | 0 |
| 2013 | 66 | 0 |
| 2014 | 91 | 0 |
| 2015 | 87 | 0 |
| 2016 | 101 | 0 |
| 2017 | 128 | 0 |
| 2018 | 117 | 0 |
| 2019 | 121 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,705)
See all 1,70513 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020152 | Synthes Vertebral Spacer TI | 2002 | 1,684 |
| K020887 | Ebi Ais Spine System | 2002 | 1,622 |
| K030744 | Blackstone Surgical Titanium Mesh | 2003 | 1,040 |
| K031302 | Sustain Spacer | 2003 | 911 |
| K041389 | Synthes Contoured Synmesh Spacer | 2004 | 272 |
| K112756 | Fortify (TM) and Fortify (TM)-R Corpectomy Spacers | 2011 | 268 |
| K050449 | Quantum Vertebral Body Replacement | 2005 | 197 |
| K121176 | STGC | 2012 | 59 |
| K032371 | Titanium Mesh System | 2004 | 26 |
| K070381 | Theken VU Mesh VBR System | 2007 | 25 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2020 | Class III | Z-0408-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0412-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0416-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0407-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0409-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0411-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0413-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0414-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0403-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0404-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0405-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0406-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0410-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| Sep 21, 2020 | Class III | Z-0415-2021 | Unknown/Undetermined by firm | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
The 5 latest of 14 recalls; the web page lists all.
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?
- Of its descendants, K020152 (Synthes (Usa), 2002) has gone furthest, with 1,684 descendants of its own.
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 | — |
https://510kreport.com/device/K003275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003275: Synthes Synmesh Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003275
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026