Wednesday, August 19, 2009

FDA Clearances of 510(k)s

The Spine Blogger can report that based on the recent FDA 510(k) clearance report, there were 20 companies within our industry that received approval to launch new products.

Aesculap - Minimally Invasive Lumbar Implant (MILI) System (Original?)
Allez Spine - DelMar Monoaxial Pedicle Screw System (Are they still in business?)
Biomet/EBI- Polaris 5.5mm Pedicle Screw System (Addendum to 1/4" Rod)
Globus - Zyfuse Facet Fixation
LDR - Cervical Interbody Fusion System
Life Spine - Conquest Spinal System (Top Loading Thoracolumbar System)
Medicrea - PASS LP Spinal System (Ultra Low-Profile Polyaxial Screw System)
Meditech Advisors - Talos Interbody Fusion Device
Medtronic - CD Horizon Spinal System
Nuvasive - SpheRx II Pedicle Screw System
Sanacor - Alpine Pedicle Screw System (Located in Pleasant Grove, UT)
Signus - Nubic and Rabea Devices
Spinal Edge - Titan Pedicle Screw System (Rockville, MD based company)
Spinal Elements - Mercury Spinal System (I thought this was launched in 2007?)
Spinal USA - Anterior Lumbar Plate
Synthes Spine - Oracle Plate (Minimally invasive lateral approach device to compete with XLIF)
Ti-Tamed - Ti-Tamed Spinal System
Vertebral Technologies - Modification to Interfuse Interbody Device

So the question that must be asked is who is Ti-Tamed Spinal Systems? Have any of our readers ever heard of this company? They seem to be a european based operation. The most interesting company is Sanacor! Supposedly, they have been around since 2004. Website They have some "cool" and innovative technology. Check out the Pedicle Screw and the gold interbody device, I call it the VerteJack. Anyway it's time to start getting ready to go to work, the sun is starting to rise and I'll be heading down the coast. Have a great day!


  1. is there really any innovative spine technology here?

  2. does anyone have any information on the internal affairs of Spinewave. I am hearing Spinewave have not paid earned bonuses, "stiffed" distributors on commissions earned and will pull the line with out any notice.

    1. There's more than that to know. Just food for thought.

  3. how does sanacor product compare with spinewave?