# K192117: Small VBR™

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Nov 1, 2019 after 87 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: 15 generations back to K841189 (1984). 63 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173982: FORTIFY Corpectomy Spacers, Globus Medical, Inc. (2018) Summary page 5.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 5.
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 5.

## Most influential descendants
- K211892: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (2022), 2 descendants of its own
- K252686: EffortMed PEEK Cages & Corpectomy Cages (2025), 1 descendant of its own
- K200235: KONG-TL VBR System, KONG-C VBR System (2020), 1 descendant of its own
- K260850: Osteomni Spinal Cages System (2026), 0 descendants of its own
- K232790: KONG®-TL VBR System and KONG® C VBR System (2024), 0 descendants of its own

## Indications for use
The Small VBR 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 Small VBR 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 Small VBR 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 Small VBR is optional.

Source page: https://510kreport.com/device/K192117
Methodology: https://510kreport.com/methodology