510(k) · Cleared
ClearedStryker Spine Vertebral Body Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MQP Spinal Vertebral Body Replacement Device
Cleared on Jan 8, 2004 after a 29-day review. The FDA summary names its predicate without a number. 2 of the 897 devices in its family, counting itself, have a Class I recall. 896 later devices descend from it.
- Decided
- Jan 8, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
896 later devices descend from it, 1 citing it directly. 2 of the 897 devices in this family, counting this one, have a Class I recall.
- This deviceK033837 Stryker Spine Vertebral Body Support SystemHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 895 of its ownK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- Descendant · 2 generations on · 894 of its ownK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- Descendant · 2 generations on · 892 of its ownK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- Descendant · 2 generations on · 829 of its ownK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- Descendant · 3 generations on · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
Showing 5 of 896 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 896 · See all- K040731Stryker Spine Vertebral SpacerStryker Spine · 2004 · cites it directly895descendants
- K042571Stryker Spine Avs TL Peek SpacerStryker Spine · 2005 · 2 generations on894descendants
- K050624Stryker Spine Avs PL Peek SpacerStryker Spine · 2005 · 2 generations on892descendants
- K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005 · 2 generations on829descendants
- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · 3 generations on789descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033837 | Stryker Spine Vertebral Body Support System | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| +2 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| +2 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| +2 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| +3 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 1 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 11 | 0 |
| 2013 | 10 | 0 |
| 2014 | 26 | 0 |
| 2015 | 22 | 0 |
| 2016 | 34 | 0 |
| 2017 | 63 | 0 |
| 2018 | 62 | 0 |
| 2019 | 76 | 0 |
| 2020 | 82 | 0 |
| 2021 | 74 | 1 |
| 2022 | 80 | 0 |
| 2023 | 92 | 0 |
| 2024 | 92 | 0 |
| 2025 | 77 | 0 |
| 2026 | 70 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | — | Surgical Dynamics Mesh Cage System Named without a submission number |
What descends from it? (896)
See all 8961 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040731 | Stryker Spine Vertebral Spacer | 2004 | 895 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- Of its descendants, K040731 (Stryker Spine, 2004) has gone furthest, with 895 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 | — |
What is it indicated for?
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (Ti-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). For both corpectomy and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033837 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033837: Stryker Spine Vertebral Body Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033837
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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