# K172032: Modulift Vertebral Body Replacement (VBR) System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implants Systems, Inc.
- Decided: Nov 20, 2017 after 138 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- 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: 15 generations back to K003155 (2001). 57 ancestors in all.
46 later devices descend from it; 6 cite it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151651: NuVasive X-CORE Mini Cervical Expandable VBR System, Nu Vasive, Incorporated (2015) Summary page 5.
- K110864: Biospine VBR System, Aesculap Implant Systems, LLC (2011) Summary page 5.
- K133802: Ais Modulift VBR System, Aesculap Implant System, Inc. (2014) Summary page 5.
- K142150: Ais Modulift VBR System, Aesculap Implant System, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K172032
Methodology: https://510kreport.com/methodology