Wednesday, January 20, 2010

FDA Clearances of 510(k)s

Captiva Spine: Pivotec Lumbar Interbody Fusion Device
Choice Spine: Anterior Cervical Plating System
Custom Spine: Pathway Ivb/Vbr
Globus Medical: Patriot Transcontinental Llif Spacer
K2M: Modification to Caspian Spinal System
Lanx LLC: Modification to Lanx Spinal Fixation System
Life Spine: Stand-Alone Spacer
Medtronic: Modification to CD Horizon Spinal System
Stryker Spine: Xia 4.5 Spine, AVS Pl PEEK Spacer
VTI: InterFuse Invertebral Body Fusion Device Model 9076


  1. Any clue as to what the Llif Spacer from Globus is?

  2. Guessing a Lateral Cage to compete with Nuvasive and the Medtronic DLIF.

  3. Probably something that is copied from other companies. There idea base has got to be getting low.

  4. They never had an idea base. They carefully copy an existing device, ask the patent laywers if they need to add one spike to circumvent any IP, and that's it. In the beginning they had it easier, they used the Synthes blueprints.

  5. Glad to see all the other companies clearances are for fixing the crap they originally tried to shove down the docs throats. Oh wait, there are a couple of me-toos there.

    Anonymous said: waa waa waa all the home to Exton.

  6. @Anonymous 1 & 2:
    Yes, Globus is coming out with their version of a far lateral approach system.

    @Anonymous2: DePuy's also been working on a far lateral device. Expect many companies to be working on a me2 xlif system. Now how the reimbursement goes and to what extent it affects product development plans is an entirely different question. I'm sure there are a lot of people with vested interests paying close attn to this topic.

  7. NuVasive pays the majority of the doctors to start using the XLIF, they are the consultanting agreement heavy company. Pay for play has paid off so far.

  8. NuVasive pays the surgeons? You are just plain WRONG. Thats Globus' job...

  9. Anybody know what the "K2M: Modification to Caspian Spinal System" is about? What did they have to modify and why?

  10. To the guy who says Nuva pays docs to start using XLIF is a complete moron. I have taught many surgeons how to do this procedure, non who have been paid!! Most competent surgeons love it on it's own merit!