510(k) · Cleared
ClearedNormandy VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation Medical Products, LLC · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Jul 13, 2018 as substantially equivalent to K162315 (Globus Medical, Inc., 2017) and 3 other predicates after a 121-day review. Its family tree reaches back 16 generations to 2001. 7 later devices descend from it.
- Decided
- Jul 13, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K003155 (2001). 84 ancestors in all, the oldest K841189 (1984). 7 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 2 generations backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 1 generation backK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- This deviceK180673 Normandy VBR SystemZavation Medical Products, LLC · 2018
- Descendant · cites it directly · 4 of its ownK183071 VLIFT-s Vertebral Body Replacement SystemStryker Spine · 2019
- Descendant · cites it directly · 3 of its ownK191423 Normandy VBR SystemZavation Medical Products, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK211320 CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 10 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 9 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 8 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 7 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 6 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 5 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 4 generations backK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- 3 generations backK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 2 generations backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 1 generation backK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- This deviceK180673 Normandy VBR SystemZavation Medical Products, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine · 2019 · cites it directly4descendants
- K191423Normandy VBR SystemZavation Medical Products, LLC · 2019 · cites it directly3descendants
- K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022 · 2 generations on2descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −10 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −6 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −5 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −4 | K110864 | Biospine VBR System | Aesculap Implant Systems, LLC | 2011 | — |
| −3 | K133802 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| −2 | K142150 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| −1 | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
| 0 (this device) | K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018 | — |
| +1 | K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019 | — |
| +1 | K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019 | — |
| +2 | K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022 | — |
| +2 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +2 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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.
Planning a device in PLR? 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 PLR device
- #1 K232481 RIGEL™ 3DR Anterior Cervical Corpectomy Systemscore 13.1 · 24 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 |
|---|---|---|---|
| * | K162315 | FORTIFY Corpectomy SpacersSummary page 4…Regulatory Class: Class II Product Code: PLR, MQP Predicates: Primary: K162315 Globus FORTIFY Corpectomy Spacers Additional: K060416 Ulrich Medical Obelisc… | 2017 |
| * | K060416 | Obelisc Vertebral Body Replacement DeviceSummary page 4…Product Code: PLR, MQP Predicates: Primary: K162315 Globus FORTIFY Corpectomy Spacers Additional: K060416 Ulrich Medical Obelisc K012254 Osteotech VBR… | 2006 |
| * | K012254 | VBRSummary page 4…2315 Globus FORTIFY Corpectomy Spacers Additional: K060416 Ulrich Medical Obelisc K012254 Osteotech VBR K172032 Aesculap Modulift VBR… | 2001 |
| * | K172032 | Modulift Vertebral Body Replacement (VBR) SystemSummary page 4…Additional: K060416 Ulrich Medical Obelisc K012254 Osteotech VBR K172032 Aesculap Modulift VBR Reference: K112664 Zavation IBF Device Description: The Normandy… | 2017 |
| † | K112664 | Zavation Ibf Systems | 2011 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 7 of the 84 ancestors have a recall of any class.
- Of its descendants, K183071 (Stryker Spine, 2019) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K162315.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The Normandy VBR System is…
Read the full statement (198 words)
The Normandy VBR System is indicated for use in the cervical spine (C2-C7), and thoracolumbar spine (T1-L5) in
skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve
decompression of the spinal cord and neural tissues in degenerative disorders.
The Normandy VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft, as an adjunct to fusion. The Normandy VBR System is also intended to restore the integrity
of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors
involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit
achievement of fusion, with bone graft used at the surgeon’s discretion.
The Normandy VBR System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been
labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior plate
systems). When used at more than two levels, supplemental fixation should include posterior fixation.
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/K180673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180673: Normandy VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180673
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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