510(k) · Cleared
ClearedModulift Vertebral Body Replacement (VBR) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implants Systems, Inc. · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Nov 20, 2017 as substantially equivalent to K151651 (Nu Vasive, Incorporated, 2015) and 3 other predicates after a 138-day review. Its family tree reaches back 15 generations to 2001. 46 later devices descend from it.
- Decided
- Nov 20, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K003155 (2001). 57 ancestors in all, the oldest K841189 (1984). 46 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- 2 generations backK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 1 generation backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- This deviceK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- Descendant · cites it directly · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 3 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- Descendant · 4 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 5 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 9 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 8 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 7 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 6 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 5 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 4 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 3 generations backK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- 2 generations backK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- 1 generation backK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- This deviceK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · cites it directly28descendants
- K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 2 generations on27descendants
- K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019 · 3 generations on21descendants
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · 4 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −9 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −8 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −5 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −4 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −3 | K110864 | Biospine VBR System | Aesculap Implant Systems, LLC | 2011 | — |
| −2 | K133802 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| −1 | K142150 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| 0 (this device) | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
| +1 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +3 | K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| +4 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +5 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR SystemSummary page 5…d the indications to include use in the cervical spine (C3-C7) of the small VBR devices. Primary Predicate Device: NuVasive X-CORE® Mini Cervical Expandable VBR System (K151651). Additional Predicate Device: Aesculap Implant Systems (AIS) Modulift VBR System (K110864/K133802/K142150) Comparison of Techn… | 2015 |
| * | K110864 | Biospine VBR SystemSummary page 5…imary Predicate Device: NuVasive X-CORE® Mini Cervical Expandable VBR System (K151651). Additional Predicate Device: Aesculap Implant Systems (AIS) Modulift VBR System (K110864/K133802/K142150) Comparison of Technological Characteristics: The purpose of this 510(k) is to modify the Indications for Use fo… | 2011 |
| * | K133802 | Ais Modulift VBR SystemSummary page 5…edicate Device: NuVasive X-CORE® Mini Cervical Expandable VBR System (K151651). Additional Predicate Device: Aesculap Implant Systems (AIS) Modulift VBR System (K110864/K133802/K142150) Comparison of Technological Characteristics: The purpose of this 510(k) is to modify the Indications for Use for the su… | 2014 |
| * | K142150 | Ais Modulift VBR SystemSummary page 5…Device: NuVasive X-CORE® Mini Cervical Expandable VBR System (K151651). Additional Predicate Device: Aesculap Implant Systems (AIS) Modulift VBR System (K110864/K133802/K142150) Comparison of Technological Characteristics: The purpose of this 510(k) is to modify the Indications for Use for the subject Mo… | 2014 |
What descends from it? (46)
See all 466 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | 2018 | 28 |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | 2018 | 9 |
| K180673 | Normandy VBR System | 2018 | 7 |
| K183071 | VLIFT-s Vertebral Body Replacement System | 2019 | 4 |
| K212126 | MediExpand Cervical Expandable VBR System | 2022 | 0 |
| K190284 | Bengal Stackable Cage System | 2019 | 0 |
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 16 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 5 of the 57 ancestors have a recall of any class.
- Of its descendants, K181328 (Medtronic Sofamor Danek USA, Inc., 2018) has gone furthest, with 28 descendants of its own.
- 8 other devices also cite its predicate K151651.
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. 2017, 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 Modulift VBR System is indicated for use in the cervical spine (C3-C7 vertebral bodies for the small VBR implant) and thoracolumbar spine (T1-L5 vertebral bodies for the small/medium/large VBR implant) 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…
Read the full statement (274 words)
The Modulift VBR System is indicated for use in the cervical spine (C3-C7 vertebral bodies for the small VBR implant) and thoracolumbar spine (T1-L5 vertebral bodies for the small/medium/large VBR implant) 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 Modulift 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 Modulift 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 Modulift VBR System is intended to be used with supplemental fixation systems that have been cleared by the FDA. When used in the thoracolumbar spine, the Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. When used in the Cervical Spine at one or two levels, the Modulift Vertebral Body Replacement (VBR) System is intended to be used with supplemental fixation systems (i.e., ABC Anterior Cervical System or the Quintex Cervical System). When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA (i.e., Aesculap S4 Cervical System).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172032: Modulift Vertebral Body Replacement (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/K172032
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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