# K232173: Ascend VBR System, Ascend NanoTec VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 6, 2023 after 77 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: 23 generations back to K841189 (1984). 279 ancestors in all.
No later device cites it as a predicate yet.
1 of 280 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192117: Small VBR™, Ulrich GmbH & Co. KG (2019) Summary page 5.
- K050553: Novel VBR Spinal System, Alphatec/Nexmed (2005) Summary page 5.
- K193506: NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System, Nu Vasive, Incorporated (2020) Summary page 5.

## Indications for use
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a 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 Ascend 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 Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional. The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a 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 Ascend NanoTec 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 Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

Source page: https://510kreport.com/device/K232173
Methodology: https://510kreport.com/methodology