510(k) Report

510(k) · Cleared

Cleared

Aesculap Hydrolift VBR System

K083186510(k) TraditionalCleared Mar 4, 2010491-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesculap Implant System, Inc. · MQP Spinal Vertebral Body Replacement Device

Cleared on Mar 4, 2010 as substantially equivalent to K003836 (Synthes, 2001) and 1 other predicate after a 491-day review. Its family tree reaches back 3 generations to 1984. 51 later devices descend from it.

Decided
Mar 4, 2010
Review
491 days
Class
Class II
Product code
MQP
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K841189 (1984). 5 ancestors in all. 51 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor2011: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2019: 5 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2024: 8 descendants cleared2023: 5 descendants cleared2025: 10 descendants cleared2022: 1 descendant cleared2021: 2 descendants cleared2026: 14 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 7 descendants6 generations forward: 15 descendants7 generations forward: 8 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant K003836 · Synthes Synex Spacer System · Synthes · 2001 · recalledK990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 19840+5
  1. Root · 3 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 2 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 1 generation backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
  4. This deviceK083186 Aesculap Hydrolift VBR SystemAesculap Implant System, Inc. · 2010
  5. Descendant · cites it directly · 47 of its ownK173125 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  6. Descendant · 2 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
  7. Descendant · 2 generations on · 27 of its ownK183510 T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2019
  8. Descendant · 3 generations on · 21 of its ownK191066 CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
  9. Descendant · 4 generations on · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2011: 12014: 12017: 12018: 12019: 52020: 22021: 22022: 12023: 52024: 82025: 102026: 14
2011high 14 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 51 · See all
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017 · cites it directly47descendants
  • K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on28descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−2K990148Stackable Cage SystemDepuy Motech Acromed1999—
−1K003836Synthes Synex Spacer SystemSynthes200111
0 (this device)K083186Aesculap Hydrolift VBR SystemAesculap Implant System, Inc.2010—
+1K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek2017—
+2K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.2018—
+2K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.2019—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2019—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD…Medtronic Sofamor Danek USA, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
201710
201810
201950
202020
202120
202210
202350
202480
2025100
2026140
FIG. 1 — Lineage of K083186, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MQP? 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. #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003836Synthes Synex Spacer System
Summary page 1
…NTIAL EQUIVALENCE Aesculap® Implant Systems, Inc. believes that the Aesculap Hydrol-ift VBR System is substantially equivalent to: 1) SynEx Spacer System by Synthes (K003836) 2) Lift VB Spinal System by Medtronic Sofamor Danek, Inc. (K010930) DEVICE DESCRIPTION The Aesculap Hydrol-ift VBR System is…
Synthes200111
*K010930Lift VB Spinal System
Summary page 1
…Aesculap Hydrol-ift VBR System is substantially equivalent to: 1) SynEx Spacer System by Synthes (K003836) 2) Lift VB Spinal System by Medtronic Sofamor Danek, Inc. (K010930) DEVICE DESCRIPTION The Aesculap Hydrol-ift VBR System is an adjustable vertebral body replacement device that is implanted i…
Medtronic Sofamor Danek, Inc.2001—

Also cleared against K003836: 8 other devices →

What descends from it? (51)

See all 51

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747
K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190
K140563Lateral VBR SystemNu Vasive, Incorporated20140
K110153SFC Vertebral Body ReplacementKonigsee Implantate GmbH20110

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 26 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K173125 (Medtronic Sofamor Danek, 2017) has gone furthest, with 47 descendants of its own.
  • 8 other devices also cite its predicate K003836.

How does its category compare?

All MQP devices

MQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MQP

4in 2024

2007: 302008: 172009: 112010: 62011: 82012: 72013: 32014: 52015: 82017: 92018: 62019: 82020: 32022: 12023: 12024: 42026 (partial year): 3
2007high 30 (2007) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQP

187in 2024

2007: 107 days median2008: 47 days median2009: 115 days median2010: 174 days median2011: 237 days median2012: 82 days median2013: 90 days median2014: 125 days median2015: 126 days median2017: 97 days median2018: 152 days median2019: 93 days median2020: 103 days median2024: 187 days median2026 (partial year): 102 days median
2007high 237 (2011) · low 47 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQP

1in 2022

2007: 22009: 142010: 22011: 12012: 22020: 152022: 1
2007high 15 (2020) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQP

168in 2025

2007: 612008: 762009: 1112010: 1662011: 1212012: 1412013: 2072014: 2162015: 2582016: 1292017: 1412018: 1302019: 1172020: 1572021: 2082022: 1372023: 712024: 982025: 168
2007high 258 (2015) · low 61 (2007)2025

MAUDE reports naming product code MQP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200730107261
20081747076
20091111514111
201061742166
201182371121
20127822141
20133900207
201451250216
201581260258
20160—0129
20179970141
201861520130
20198930117
2020310315157
20210—0208
20221—1137
20231—071
20244187098
20250—0168
202631020—

What is it indicated for?

The Aesculap HydraL-ift VRR System is indicated for use in the thoracolumbar spine (Ti to L-5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap Hydral-ift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or 54 Systems. The Aesculap HydraL-ift VBR System may be used with bone graft. The Aesculap HydroL-ift VBR System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Indications for use as stated in the FDA summary.

Also cleared against K003836

8 other devices cite the same predicate.

  • K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
  • K103320Synthes XRLSynthes Spine Co.Lp · 20111 recall
  • K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC · 2007
  • K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc · 2007
  • K061891Synex IISynthes Spine Co.Lp · 2006
  • K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine · 2006

More from Aesculap Implant System, Inc.

18 FDA decisions under this applicant name. See the company

  • K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc. · 2014
  • K142150Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
  • K133802Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
  • K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc. · 2013
  • K130887S4C Navigation InstrumentsAesculap Implant System, Inc. · 2013

Recent decisions in MQP

The MQP category page

  • K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
  • K261031Poseidon STSignus Medinzintechnik GmbH · 2026
  • K253158VyBrate™ VBR SystemVy Spine, LLC · 2026
  • K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
  • K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024

https://510kreport.com/device/K083186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083186: Aesculap Hydrolift 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/K083186

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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