510(k) · Cleared
Recalled · 2009Synthes Synex Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes · MQP Spinal Vertebral Body Replacement Device
Cleared on May 29, 2001 as substantially equivalent to K001340 (Depuyacromed, 2000) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1984. 1 of the 1,334 devices in its family, counting itself, has a Class I recall. 1,330 later devices descend from it. It has been recalled 11 times.
- Decided
- May 29, 2001
- Review
- 168 days
- Class
- Class II
- Product code
- MQP
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 2 generations to K841189 (1984). 3 ancestors in all. 1,330 later devices descend from it, 9 citing it directly. 1 of the 1,334 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 1 generation backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- This deviceK003836 Synthes Synex Spacer SystemSynthes · 2001
- Descendant · cites it directly · 1,280 of its ownK032064 Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc · 2004 · Recalled
- Descendant · 2 generations on · 1,214 of its ownK043479 MC+ Partial VBRLdr Spine USA · 2005
- Descendant · 3 generations on · 903 of its ownK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- Descendant · 3 generations on · 902 of its ownK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- Descendant · 3 generations on · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
Showing 5 of 1,330 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 1,330 · See all- K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc · 2004 · cites it directly1,280descendants
- K043479MC+ Partial VBRLdr Spine USA · 2005 · 2 generations on1,214descendants
- K080728LDR Spine Roi-C ImplantLdr Spine USA · 2008 · 3 generations on903descendants
- K083857LDR Spine Roi-C ImplantLdr Spine USA · 2009 · 3 generations on902descendants
- K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · 3 generations on901descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −1 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| 0 (this device) | K003836 | Synthes Synex Spacer System | Synthes | 2001 | — |
| +1 | K032064 | Theken Cpod/Lpod Vertebral Body Replacement System | Theken Surgical,Llc | 2004 | 1 |
| +2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| +3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| +3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| +3 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 9 | 0 |
| 2011 | 24 | 0 |
| 2012 | 32 | 0 |
| 2013 | 39 | 0 |
| 2014 | 67 | 0 |
| 2015 | 73 | 0 |
| 2016 | 84 | 0 |
| 2017 | 117 | 0 |
| 2018 | 105 | 0 |
| 2019 | 105 | 0 |
| 2020 | 98 | 0 |
| 2021 | 88 | 1 |
| 2022 | 85 | 0 |
| 2023 | 108 | 0 |
| 2024 | 107 | 0 |
| 2025 | 82 | 0 |
| 2026 | 81 | 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? (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 |
|---|---|---|---|
| * | K001340 | Stackable Cage SystemSummary page 1…60: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87. Depuy AcroMed Stackable Cage System - K001340 - K990148 The SynEx device is a cylindrically-shaped titanium vertebral implant with a hollow core; the walls and endplates have… | 2000 |
| * | K990148 | Stackable Cage SystemSummary page 1…t, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87. Depuy AcroMed Stackable Cage System - K001340 - K990148 The SynEx device is a cylindrically-shaped titanium vertebral implant with a hollow core; the walls and endplates have a plurali… | 1999 |
What descends from it? (1,330)
See all 1,3309 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032064 | Theken Cpod/Lpod Vertebral Body Replacement System | 2004 | 1,280 |
| K050058 | Theken Reveal VBR System | 2005 | 727 |
| K070082 | XY Cor Spinal Implant for Minimal Invasive Spinal Surgery | 2007 | 641 |
| K060506 | Stryker Spine Vlift Vertebral Body Replacement System | 2006 | 270 |
| K061891 | Synex II | 2006 | 77 |
| K142205 | NuVasive X-CORE (R) Expandable VBR System | 2015 | 74 |
| K083186 | Aesculap Hydrolift VBR System | 2010 | 51 |
| K103320 | Synthes XRL | 2011 | 3 |
| K070786 | X-Pod Adjustable Vertebral Body Replacement | 2007 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2009 | Not classified | Z-0109-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0110-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0111-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0115-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0113-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0117-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0118-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0114-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0108-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0112-2010 | Device Design | loss of device height |
| Sep 14, 2009 | Not classified | Z-0116-2010 | Device Design | loss of device height |
The 5 latest of 11 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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032064 (Theken Surgical,Llc, 2004) has gone furthest, with 1,280 descendants of its own.
- 16 other devices also cite its predicate K001340.
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 SynEx™ 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 SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynEx™ Spacer System can be packed with bone.
The SynEx™ Spacer is 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/K003836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003836: Synthes Synex Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003836
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026