Sunday, January 30, 2011

Who's NEXXT in Spine? 510(k) Clearances

As TSB was reviewing December's 2010's FDA Clearances of 510(k's) we stumbled upon a pedicle screw cleared for a company named NEXXT Spine.  Based in Indiana, NEXXT's tagline touts that it is "advancing the business of internal fixation.  Currently they have a cervical plate and pedicle screw.  The company is led by Andrew Elsbury, with Brian Wicker as the Head of Sales.  If anyone is interested in picking up some additional product or looking to help these guys jump into the marketplace head first give 'em a holler at 317.436.7801.  So with that here are the latest clearances;

Aesulap:  Laminoplasty Plating System (Big Market)
Carefusion: Enview
DePuy Spine: Concorde Curve System
DePuy Spine: Viper System
DePuy Spine: Expedium Spine System
Genesys Spine: Interbody Fusion System
Globus: Patriot Transcontinental M Spacers
MDT: TSRH Spinal System
MDT: Sustain Space Maintenance System
Medyssey:  Zenius Spinal System
Medyssey: Novell III Spinal Fixation/Adjustable Bridge Plate
NEXXT Spine: Inertia Pedicle Screw System
NUVA: Spherx II Mas Deformity Spinal System
Spinecraft: Apex Spine System w/CoCr Rods
Synthes Spine: Zero-P
Theken Spine: Cervical Standalone IVB Fusion Device (they're multiplying faster than a rabbit)
Zyga Technology: SImmetry SI Joint Fusion System (get it SI - SImmetry)

So here it is folks, read and weep.


  1. The magnitude of the post that I would need to write to convey how I feel about this is overwhelming. So I won't even try. But the gravity of knowing that they have a cervical plate and pedicle screw keeps pulling me back.

    Is Wicker sporting a faux hawk?

    Seriously? Really?

    I feel like I need to take a shower.

  2. Wicker is no longer w/ them.

  3. That Genesys system is complete crap.

  4. George W. Bush was the keynote speaker at the Nuva National Sales Meeting in San Diego this past weekend. It doesn't matter if you're a Democrat, a Republican, or an Indie...that sh*t is cool!

  5. Why not, 150k is chump change to NUVA.

  6. Maybe next year they'll hire TSB. At least they'll have more fun and there will be no Cheetah Ball

  7. I've seen it referenced a few times here....what is "cheetah ball"?

  8. Cheetah ball - located on a male cheetah however it usually comes in two's.

  9. 150k for a keynote speaker. That is embarrassing.

  10. especially since this one can't speak.

  11. They should have spent that $150k on free XLIFs for the poor, uninsured, and pain-ridden in East County San Diego. Unfortunately, that would not boost the already massive bank accounts and egos of those in La Jolla. I agree with 8:53, completely embarrassing.

  12. "There's an old saying in Tennessee — I know it's in Texas, probably in Tennessee — that says, fool me once, shame on — shame on you. Fool me — you can't get fooled again."

  13. Laura and I would like to thank Alex for inviting us, ahem.... you don't mine if I call you chubby? Nexium is a great company, I apologize I meant Nuvasive is a great company, I got confused with the color purple and it must have been a sub-conscious slip since I have heartburn from the lunch I just had. I hear y'all in the management team musta worked in the deep South in a previous lifetime well if you can' t be in Crawford, LaJolla may be the next best thing. Well gotta go, and oh by the way cash would be fine.

  14. The Nexxt Spine business model involves selling directly to hospitals. They want to cut sales reps, or what they call "Middle Men" out. Their plan involves paying high commissions intially then once they have surgeons they will cut commissions to 5% and cut prices by 50%. Ironic thing is that it is run by K2M (Wyatt) and Lanx (Buhner) distributors that got rich as "Middle Men". Their greed has now driven them to try and destroy that career opportunity.

  15. SIMPLIFIED BUSINESS PLAN - Nexxt Spine LLC business plan can be simplified down to three stages.

    1. Create sellable products to meet surgeon demands.

    2. Build infrastructure while proving product acceptance

    at “Alpha” surgery sites.

    3. Sell nationally initially via “Traditional” distribution

    channel and long term via “Direct” sales channel.

    Nexxt Spine successfully completed stages 1 and 2 and is now seeking additional funds to execute stage 3 to sell nationally!

    Stage 1 included the following accomplishments: designing two implant systems (lumbar pedicle screw & cervical plate) with two patents pending, and both cleared to market by the FDA. Also designing and sourcing all accompanying instruments.

    Stage 2 included the following accomplishments: surgeon acceptance documented by over 100 successful surgeries in 12 months, implementation of a manufacturing facility producing all of our implants, and assembling a skilled team of employees poised for growth.

    Nexxt Spine completed stages 1 and 2 in less than two years and have real cash flows, proving we are very capable of implementing our business plan. Send us your check!

  16. Don't forget about the G6 that was sent for him, plus room and board/ hookers and blow. Oops, those were the college days.

  17. If you don't admit that you miss him your full of----! NOBAMA

  18. Jan. 31 6:30 has got to be Elsbury. He is a dork but accomplished. An accomplished dork. Wyatt controlled over 20% of K2M's biz. Cashed out big in the buy out and now is cannibalizing everything. Can't blame them for seeing a commodity opportunity. Hopefully he finally fired that cross dressing VP of Sales Pink Pants Ward!

  19. 6:30
    100 successful surgeries and you have real cash flows? That must be a peach of a manufacturing facility.

  20. Wyatt and Buhner have nothing to do with Nexxt now. They did in the beginning, but not anymore. And don't hate on "Pink Pants." Only a real man wears those!

  21. The Boys at NEXXT Spine have forgotten the golden rule of Implants. ANYONE can make this shit, It is an ART to get rid of it.

    Companies like NUVA cant even get solid distributors how is a No Time company like NEXXT going to? Its all about distribution. I think they are about 5 days and 20 million short on this weak plan. And these clowns really think they have defendable IP? RIGHT.

  22. @ 7:16. Nobama? Really? Did "Gin & Tonic" (baby bush's nickname in college) add 30 million new customers for us? No, we dropped bombs on Iraq for 5yrs instead. He also suppressed stem cell research. Great idea there too. Leave the Politics out of these discussions. Or at least use someone better than the Texan from Connecticut.

  23. NEXXT SPINE is in our area (Middle TN) and they seem to be adopting the POD model. Hopefully they get caught and we can get them out of our area for good.