510(k) · Cleared
ClearedNovel VBR Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec/Nexmed · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 7, 2004 as substantially equivalent to K021791 (Medtronic Sofamor Danek, 2002) and 1 other predicate after a 55-day review. Its family tree reaches back 3 generations to 2001. 1 of the 805 devices in its family, counting itself, has a Class I recall. 796 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003155 (2001). 8 ancestors in all, the oldest K841189 (1984). 796 later devices descend from it, 5 citing it directly. 1 of the 805 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 2 generations backK012254 VBROsteotech, Inc. · 2001
- 1 generation backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- This deviceK042201 Novel VBR Spinal SystemAlphatec/Nexmed · 2004
- Descendant · cites it directly · 789 of its ownK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- Descendant · 2 generations on · 788 of its ownK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 554 of its ownK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- Descendant · 3 generations on · 461 of its ownK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- Descendant · 4 generations on · 460 of its ownK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
Showing 5 of 796 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 796 · See all- K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006 · cites it directly789descendants
- K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc. · 2008 · 2 generations on788descendants
- K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009 · 2 generations on554descendants
- K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010 · 3 generations on461descendants
- K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011 · 4 generations on460descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −2 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −1 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| 0 (this device) | K042201 | Novel VBR Spinal System | Alphatec/Nexmed | 2004 | — |
| +1 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| +2 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| +2 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| +3 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| +4 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 16 | 0 |
| 2015 | 19 | 0 |
| 2016 | 28 | 0 |
| 2017 | 48 | 0 |
| 2018 | 53 | 0 |
| 2019 | 69 | 0 |
| 2020 | 74 | 0 |
| 2021 | 69 | 1 |
| 2022 | 72 | 0 |
| 2023 | 87 | 0 |
| 2024 | 90 | 0 |
| 2025 | 76 | 0 |
| 2026 | 69 | 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 |
|---|---|---|---|
| * | K021791 | Verte-Stack Spinal SystemSummary page 1…Trade/Proprietary Name Manufacturer Clearance Verte-Stack Spinal System Medtronic Sofamor Danek K021791 DePuy AcroMed Stackable Cage DePuy AcroMed K990148 VIII. Performance Data: S… | 2002 |
| * | K990148 | Stackable Cage SystemSummary page 1…Verte-Stack Spinal System Medtronic Sofamor Danek K021791 DePuy AcroMed Stackable Cage DePuy AcroMed K990148 VIII. Performance Data: Static and dynamic testing of the NOVEL TM VBR Spinal System was performed. The test results… | 1999 |
What descends from it? (796)
See all 7965 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K060762 (Aesculap, Inc., 2006) has gone furthest, with 789 descendants of its own.
- 11 other devices also cite its predicate K021791.
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 Novel' TM VBR Spinal System is intended for use in the thoracolumbar spine (Ti to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The NovelTM VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel T MVBR System is to be used with the Alphatec Zodiac TM Polyaxial Pedicle Screw System or the Alphatec Mirage MT Top Tightening Spinal System. Furthermore, the NovelT MVBR System is intended for use with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042201 · printed Nov 3, 2026
Cite this page
510(k) Report. “K042201: Novel VBR Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042201
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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