510(k) · Cleared
ClearedSynex II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 18, 2006 as substantially equivalent to K003836 (Synthes, 2001) and 1 other predicate after a 46-day review. Its family tree reaches back 3 generations to 1984. 77 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K841189 (1984). 4 ancestors in all. 77 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 1 generation backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- This deviceK061891 Synex IISynthes Spine Co.Lp · 2006
- Descendant · cites it directly · 74 of its ownK142205 NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
- Descendant · 2 generations on · 68 of its ownK151651 NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 57 of its ownK152568 C-VBRCardinal Spine, LLC · 2016
- Descendant · 3 generations on · 55 of its ownK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 46 of its ownK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015 · cites it directly74descendants
- K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated · 2015 · 2 generations on68descendants
- K152568C-VBRCardinal Spine, LLC · 2016 · 3 generations on57descendants
- K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017 · 3 generations on55descendants
- K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −2 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −1 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| 0 (this device) | K061891 | Synex II | Synthes Spine Co.Lp | 2006 | — |
| +1 | K142205 | NuVasive X-CORE (R) Expandable VBR System | Nuvasive, Inc. | 2015 | — |
| +2 | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| +3 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| +3 | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 11 | 0 |
| 2020 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 15 | 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 |
|---|---|---|---|
| * | K003836 | Synthes Synex Spacer SystemSummary page 1…e Panel Code 87 and Classification Product Code MQP 21 CFR 888.3060: Class 11 Predicate Device K003836 - SyneXTM Spacer Device Description The Synex 11 Spacer is a height expanding vertebral… | 2001 |
| * | K001340 | Stackable Cage SystemSummary page 2…previously cleared spinal systems, Synthes Synex, K003836, and DePuy Stackable Cage System, K001340. The supplement fixation devices for use with the Synex II are cleared for use in… | 2000 |
What descends from it? (77)
See all 773 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K142205 (Nuvasive, Inc., 2015) has gone furthest, with 74 descendants of its own.
- 8 other devices also cite its predicate K003836.
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 SynexTM II implant 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 Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS.
The Synex II device 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/K061891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061891: Synex II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061891
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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