510(k) · Cleared
ClearedExpandable Peek VBR Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device
Cleared on Aug 27, 2004 after a 140-day review. The FDA summary names no predicate by number. 1 of the 1,505 devices in its family, counting itself, has a Class I recall. 1,504 later devices descend from it.
- Decided
- Aug 27, 2004
- Review
- 140 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 0
1,504 later devices descend from it, 10 citing it directly. 1 of the 1,505 devices in this family, counting this one, has a Class I recall.
- This deviceK040928 Expandable Peek VBR ImplantInterpore Cross Intl. · 2004
- Descendant · cites it directly · 1,440 of its ownK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- Descendant · 2 generations on · 1,406 of its ownK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- Descendant · 3 generations on · 1,405 of its ownK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- Descendant · 4 generations on · 1,103 of its ownK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- Descendant · 5 generations on · 1,008 of its ownK100175 Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010
Showing 5 of 1,504 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 1,504 · See all- K042930Spacevision Cage SystemSpine Vision, Inc. · 2004 · cites it directly1,440descendants
- K062759Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007 · 2 generations on1,406descendants
- K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007 · 3 generations on1,405descendants
- K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008 · 4 generations on1,103descendants
- K100175Clydesdale Spinal SystemMedtronic Sofamor Danek · 2010 · 5 generations on1,008descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040928 | Expandable Peek VBR Implant | Interpore Cross Intl. | 2004 | — |
| +1 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| +2 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| +3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| +4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| +5 | K100175 | Clydesdale Spinal System | Medtronic Sofamor Danek | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 15 | 0 |
| 2009 | 9 | 0 |
| 2010 | 19 | 0 |
| 2011 | 36 | 0 |
| 2012 | 42 | 0 |
| 2013 | 51 | 0 |
| 2014 | 67 | 0 |
| 2015 | 73 | 0 |
| 2016 | 91 | 0 |
| 2017 | 113 | 0 |
| 2018 | 112 | 0 |
| 2019 | 107 | 0 |
| 2020 | 106 | 0 |
| 2021 | 105 | 1 |
| 2022 | 100 | 0 |
| 2023 | 135 | 0 |
| 2024 | 124 | 0 |
| 2025 | 101 | 0 |
| 2026 | 88 | 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?
The FDA summary names no predicate by number.
What descends from it? (1,504)
See all 1,50410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042930 | Spacevision Cage System | 2004 | 1,440 |
| K081636 | Peek-Optima Alif Spacer | 2008 | 542 |
| K092336 | C-Thru Spinal System | 2009 | 492 |
| K052384 | Lanx VBR System | 2005 | 455 |
| K050861 | Peek Cas | 2005 | 224 |
| K092574 | Esl Spinal System | 2010 | 181 |
| K091381 | Ibex Spinal System | 2009 | 181 |
| K112014 | Zyston Straight Spacer System | 2011 | 174 |
| K122989 | Biomet Lateral Spacer System | 2012 | 171 |
| K111294 | Santorini Spinal System | 2012 | 18 |
Has anything in its family been recalled? (1 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042930 (Spine Vision, Inc., 2004) has gone furthest, with 1,440 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 Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., TI to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040928: Expandable Peek VBR Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040928
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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