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 Aug 6, 2019 as substantially equivalent to K180673 (Zavation Medical Products, LLC, 2018) and 2 other predicates after a 69-day review. Its family tree reaches back 17 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 6, 2019
- Review
- 69 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K003155 (2001). 85 ancestors in all, the oldest K841189 (1984). 3 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 2 generations backK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- 1 generation backK180673 Normandy VBR SystemZavation Medical Products, LLC · 2018
- This deviceK191423 Normandy VBR SystemZavation Medical Products, LLC · 2019
- Descendant · cites it directly · 2 of its ownK211320 CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK221490 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL…Stryker Spine · 2023
- Descendant · 3 generations on · 0 of its ownK262061 Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium®…Stryker Spine · 2026
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 11 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 10 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 9 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 8 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 7 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 6 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 5 generations backK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- 4 generations backK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 3 generations backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 2 generations backK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- 1 generation backK180673 Normandy VBR SystemZavation Medical Products, LLC · 2018
- This deviceK191423 Normandy VBR SystemZavation Medical Products, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022 · cites it directly2descendants
- K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine · 2023 · 2 generations on1descendant
- K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −11 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −10 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −9 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −7 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −6 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −5 | K110864 | Biospine VBR System | Aesculap Implant Systems, LLC | 2011 | — |
| −4 | K133802 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| −3 | K142150 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| −2 | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
| −1 | K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018 | — |
| 0 (this device) | K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019 | — |
| +1 | K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022 | — |
| +2 | K221490 | Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved… | Stryker Spine | 2023 | — |
| +3 | K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved… | Stryker Spine | 2026 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K180673 | Normandy VBR SystemSummary page 4…Regulatory Class: Class II Product Code: MQP, PLR Predicates: Primary: K180673 Zavation Normandy VBR System Additional: K060416 Ulrich Medical Obelisc… | 2018 |
| * | K060416 | Obelisc Vertebral Body Replacement DeviceSummary page 4…Product Code: MQP, PLR Predicates: Primary: K180673 Zavation Normandy VBR System Additional: K060416 Ulrich Medical Obelisc K142205 Nuvasive X-Core Purpose:… | 2006 |
| * | K142205 | NuVasive X-CORE (R) Expandable VBR SystemSummary page 4…80673 Zavation Normandy VBR System Additional: K060416 Ulrich Medical Obelisc K142205 Nuvasive X-Core Purpose: The purpose of this submission is to add new… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211320 | CAPRI Corpectomy Cage System | 2022 | 2 |
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 18 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 7 of the 85 ancestors have a recall of any class.
- Of its descendants, K211320 (K2m, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K180673.
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. 2019, 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 as stated in the FDA summary.
https://510kreport.com/device/K191423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191423: 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/K191423
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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