# K042201: Novel VBR Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec/Nexmed
- Decided: Oct 7, 2004 after 55 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 K003155 (2001). 8 ancestors in all.
796 later devices descend from it; 5 cite it directly.
1 of 805 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.

## Most influential descendants
- K060762: Aesculap Peek Vertebral Body Replacement System (2006), 789 descendants of its own
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), 554 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own

## Indications for use
The Novel' TM VBR Spinal System is intended for use in the thoracolumbar spine (Ti to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The NovelTM VBR System is intended for use with supplemental spinal fixation systems. Specifically, the Novel T MVBR System is to be used with the Alphatec Zodiac TM Polyaxial Pedicle Screw System or the Alphatec Mirage MT Top Tightening Spinal System. Furthermore, the NovelT MVBR System is intended for use with bone graft.

Source page: https://510kreport.com/device/K042201
Methodology: https://510kreport.com/methodology