# K050553: Novel VBR Spinal System

- Pathway: 510(k) (Special)
- Applicant: Alphatec/Nexmed
- Decided: Apr 18, 2005 after 46 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
381 later devices descend from it; 8 cite it directly.
0 of 382 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NOVEL VBR Spinal System manufactured from titanium alloy: named in the summary without a submission number

## Most influential descendants
- K120570: Choice Spine Vertebral Body Replacement (VBR) Device System (2012), 322 descendants of its own
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif (2013), 251 descendants of its own
- K133967: Interbody Cage System (2014), 227 descendants of its own
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K062151: Box Peek VBR System (2006), 175 descendants of its own

## Recalls of this device
- Aug 16, 2007 · Not classified · Z-0508-2009: Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and si

## Indications for use
The NOVEL TM VBR Spinal System is intended for use in the thoracolumbar spine (T1 to L5) to replace 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 VBR System is to be used with the Alphatec Zodiac TM Polyaxial Pedicle Screw System or the Alphatec Mirage' TM Top Tightening Spinal System. Furthermore, the Novel VBR System is intended for use with bone graft.

Source page: https://510kreport.com/device/K050553
Methodology: https://510kreport.com/methodology