30 Day Trial
ORTHOKNOW logo

ORTHOKNOW content is posted to these pages in real time.

Monthly compilations are available in PDF form.

Year in Review

Spine Matrix: Nucleus Replacement Technologies

In nucleus replacement, the nucleus (center of the disc) is removed and replaced with an implant while the annulus (outer part of the disc) is maintained. Nucleus replacement could serve as a less invasive alternative to fusion and disc replacement. However, it remains one of the smaller spine segments with fewer than a dozen technologies, most of which are still in development. Here we summarize the regulatory status of nucleus replacement technologies.
 

Nucleus Replacement Technologies

Company
 
Product Description Regulatory Status

Apollo Implants
 
Unnamed Injectable nano-polymer In development

Baxano Surgical
 
PNR In Situ crosslinking elastomer Pilot clinicals in Europe launched 2008;
project on hold in U.S.

Clariance
 
NucleoFill Biocompatible coil with viscoelastic biomaterial In development

DePuy Synthes
 
Hydrafil Gelifex injectable hydrogel In preclinicals

DePuy Synthes
 
SINUX ANR Curable liquid polymer CE Mark

Gentis
 
DiscCell Injectable reverse emulsion polymer matrix Clinical study in Europe for
early stage DDD ongoing

Replication Medical
 
GelStix Hydrolyzed polyacrylonitrile as
biocompatible elongated hydrogel wand
CE Mark
SpinalCyte Unnamed
Autologous regrowth of the
spinal disc nucleus using human dermal fibroblasts
 
In final animal trials, scheduled
to last 10 months; increased in vivo monitoring by 8 weeks

SpineWave
 
NuCore Injectable, 100% synthetic recombinant protein hydrogel Pilot clinicals ongoing

Vertebral Technologies
 
InterCushion PEEK inner core with soft polyurethane outer core Feasibility trial in Canada ongoing

 

ORTHOWORLD® estimated that in 2013, spine sector revenue (excluding biologics) totaled $7.4 billion. Learn more about the spine market with your ORTHOWORLD Member benefits:

THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®

Market Segment Search
Product Launches
Regulatory Clearances

Directories and Historical Databases
Spine Device Companies
M&A Activity