# K081383: Reliance VBS System

- Pathway: 510(k) (Special)
- Applicant: Reliance Medical Systems, LLC
- Decided: Jul 2, 2008 after 47 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: 9 generations back to K841189 (1984). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063637: Reliance VBS System, Reliance Medical Systems, LLC (2007) Summary page 1.
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005) Summary page 1.
- K042201: Novel VBR Spinal System, Alphatec/Nexmed (2004) Summary page 1.
- K050449: Quantum Vertebral Body Replacement, Quantum Orthopedics, Inc. (2005) Summary page 1.
- K051454: Aleutian Spacer System, K2m, LLC (2005) Summary page 1.
- K041556: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K041452: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K040536: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K040422: Modification to Verte-Stack, Medtronic Sofamor Danek (2004) Summary page 1.
- K040167: Verte-Stack Spinal System, Medtronic Sofamor Danek (2004) Summary page 1.
- K031780: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K030736: Verte-Stack Spinal System, Extra Small Sizes, Medtronic Sofamor Danek (2003) Summary page 1.
- K030735: Modified Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K030601: Verte-Stack Spinal System, Medtronic Sofamor Danek (2003) Summary page 1.
- K023570: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K011037: Vertebral Spacer, Synthes (Usa) (2002)
- K020152: Synthes Vertebral Spacer TI, Synthes (Usa) (2002) Summary page 1.
- K024364: Synthes Vertebral Spacer TI (Curved and Narrow), Synthes (Usa) (2003) Summary page 1.

## Indications for use
The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.

Source page: https://510kreport.com/device/K081383
Methodology: https://510kreport.com/methodology