# K083186: Aesculap Hydrolift VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Mar 4, 2010 after 491 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841189 (1984). 5 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003836: Synthes Synex Spacer System, Synthes (2001) Summary page 1.
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 1.

## Most influential descendants
- K173125: T2 STRATOSPHERE™ Expandable Corpectomy System (2017), 47 descendants of its own
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 descendants of its own
- K183510: T2 STRATOSPHERE Expandable Corpectomy System (2019), 27 descendants of its own
- K191066: CD Horizon™ Astute™ Spinal System (2019), 21 descendants of its own
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM (2022), 20 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K083186
Methodology: https://510kreport.com/methodology