510(k) · Cleared
ClearedStryker Spine Vertebral Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 5, 2004 as substantially equivalent to K033837 (Howmedica Osteonics Corp., 2004) and 3 other predicates after a 136-day review. Its family tree reaches back 5 generations to 2001. 2 of the 911 devices in its family, counting itself, have a Class I recall. 895 later devices descend from it.
- Decided
- Aug 5, 2004
- Review
- 136 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K003155 (2001). 15 ancestors in all, the oldest K841189 (1984). 895 later devices descend from it, 3 citing it directly. 2 of the 911 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 4 generations backK012254 VBROsteotech, Inc. · 2001
- 3 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 1 generation backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- This deviceK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- Descendant · cites it directly · 894 of its ownK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- Descendant · cites it directly · 892 of its ownK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- Descendant · cites it directly · 829 of its ownK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- Descendant · 2 generations on · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- Descendant · 3 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
Showing 5 of 895 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 895 · See all- K042571Stryker Spine Avs TL Peek SpacerStryker Spine · 2005 · cites it directly894descendants
- K050624Stryker Spine Avs PL Peek SpacerStryker Spine · 2005 · cites it directly892descendants
- K051205Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005 · cites it directly829descendants
- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · 2 generations on789descendants
- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 3 generations on788descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −4 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −3 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −1 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| 0 (this device) | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| +1 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| +1 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| +1 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| +2 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| +3 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K033837 | Stryker Spine Vertebral Body Support SystemSummary page 1…Number 21 CFR 888.3060 Product Code MQP Predicate Devices 1) Stryker Spine Vertebral Body Support System (K033837) 2) Spinal Concepts Inc. Cadence TM and TraXisTM (K033517)… | 2004 |
| * | K033517 | Spinal Concepts Inc. Cadence and TraxisSummary page 1…Devices 1) Stryker Spine Vertebral Body Support System (K033837) 2) Spinal Concepts Inc. Cadence TM and TraXisTM (K033517) 3) PEEK TetrisT M Spinal Implant (K031780)… | 2004 |
| * | K031780 | Verte-Stack Spinal SystemSummary page 1…37) 2) Spinal Concepts Inc. Cadence TM and TraXisTM (K033517) 3) PEEK TetrisT M Spinal Implant (K031780) -- 4) Stackable Cagelm System (K990… | 2003 |
| * | K990148 | Stackable Cage SystemSummary page 1…3) PEEK TetrisT M Spinal Implant (K031780) -- 4) Stackable Cagelm System (K990148) 5) VERTE-STACK TM Spinal System (K031780) Intended Use The Stryker S… | 1999 |
What descends from it? (895)
See all 8953 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K042571 (Stryker Spine, 2005) has gone furthest, with 894 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 Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant.…
Read the full statement (116 words)
The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate rod or rod systems (XIA, Spiral Radius gOD, and Trio).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040731: Stryker Spine Vertebral Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040731
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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