Friday, February 18, 2011

510(k) Clearances

Allosource:            Allofuse Plus
Apollo Spine:        Eclipse Cervical Vertebral Spacer
Apollo Spine:        Eclipse Lumbar Vertebral Spacer
Baxano:                 IO-Flex Catheter
Carefusion:            Avamax Vertebral Balloon
Eminent Spine:      King Cobra Anterior Cervical Plate (Just what we needed)
Globus Medical:    Caliber Spacer
K2M:                     Caspian Spinal System
Mazor Surgical:     Emerald Spinal System
MSD:                    Cd Horizon Spinal System
Orthovita:              Orthovita Peek Spacer
Synthes:                6.0mm CoCr and CPTi-3 Rods
Synthes:                Norian Drillable Inject Fast Set Putty (is that any different than Slo-Set?)

So here they are fellow bloggers, read 'em and weep/

38 comments:

  1. Who the hell is eminent spine, apollo spine, baxano, carefusion, and mazor surgical? I officially can't keep up anymore.

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  2. You can see 'em all in the hardware section at your local Super WalMart.

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  3. Interesting to have CoCr and CPTi rods mentioned in the same breath. Were they in the same 510k? Two very different sets of mechanical properties. Perhaps one of the experts among us can highlight the differences?

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  4. Surprised FDA let Eminent slip one past them while under scrutiny. Check out the warning letter they got from FDA. I've heard of sloppy, but this just about takes the cake. On par with the carelessness of Allez Spine, I mean Phygen. Operating this way is figuratively and literally criminal.

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm234102.htm

    Gee, how can I distribute some of your fine devices Eminent? Please be sure to send me only the good devices, send the discrepant devices to other dists.

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  5. Eminent is a joke for a company.

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  6. There's always a POD around to sell to. I'm sure Eminent can get a meeting with Alliance Surgical at their AAOS booth. Forget quality.....what's the price?

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  7. Is Zimmer Spine up for sale? Wonder...Who's gonna buy them? and, more importantly why?

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  8. 1:00pm I'm curious, why would think Zim Spine is up for sale?

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  9. I like the colors of Eminent's tools. Zebra rainbow is classy. I <3 the big snake.

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  10. Doubt Zimmer Spine is for sale but wouldn't be surprised. They just came out with a really nice upgrade to their Pathfinder system and they also got trabecular metal approved for cervical fusions so they can finally market the stuff and show studies. They have been in a downward spiral the past few years however.

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  11. CoCr = stiff as hell, but strong. Some patients may have a Nickel allergy. Used for bearing surfaces (i.e. TDR/TKA/THA)
    CPTi = softer than alloy titanium rods, but like Titanium rods, notch sensitive (i.e. small nick can propagate a crack).

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  12. Shocking not to see Stryker Spine on this list......again

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  13. Don't worry, Stryker is launching a revolutionary new system in 12 months designed to do a fusion from a lateral approach. They are so cutting edge. Some might say they'll be eleventieth to market. But Stryker will say "Hey, we're getting better!". I'm happy as hell I bolted from that wreck. Cutthroat mentality with anemic product launches pushing marginal goods.

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  14. ZS can now show images of metal in the neck? Wow good luck on assessing an adjacent level with a hunk of Trabecular Metal above or below.

    Upgrade to the almost 10 year old Pathfinder system? How very "zimmer like" to update a system once every 5 or 10 years. Most real spine companies launch, tweak, and obsolete systems in 4 years.

    Now that Dynesys is dead I can't imagine anyone is interested in buying ZS unless they have some motherlode of IP that Z doesn't have a clue about. The ZS distributors are not "exclusive" - they represent so many other products (corporate doesn't want to know) and the AVPs encourage this behavior (especially the "leaders" cough cough that came from Abbott that encourage this behavior so distributors can "get creative") i.e. declining sales and nose diving market share = no real value in the ZS distribution network.

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  15. Orthovita PEEK? WTF?

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  16. 3:11-All of the ZS distributors were/are the original ZS distributors prior to the Abbott purchase...Also, most of the management that came over with Abbott bailed about a year ago. In less than 24 months after the purchase they lost ( as in self-ejected): Group President, President, VP of Marketing, VP of Sales, 3 RM's, 3 AVP's, countless marketing folks, and I heard at AAOS that they also just lost their newly minted VP of Marketing. So, I doubt Abbott "leadership" has had much to do with the complete and utter cluster "f" of the merger and integration. The blame lies squarely on Zimmer's CEO and the "I am spine King, but I can only push Dynesys" ZS distributors. Paul G has his hands full in trying to right the ship. Who knows if he can do it, especially with the Warsaw attorneys micro-managing his every move. Good luck...p.s. nice booth at AAOS...real Smurfy

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  17. hey 9:21-- I think they are a few Abbott Sales Directors left that have done a pretty good job alienating customers, losing business, and blaming everyone else for their poor business decisions. Those Abbott folks just can't write checks like they used to when you could hire a surgeon's first assist to be a distributor. If memory serves the former "interim" VP of Sales was an Abbott dude who busted back down to an AVP job because, allegedly, he created a poisonous environment. Seriously, how hard could it be to be the Z Spine VP of Sales?

    Also > wtf are both the Minneapolis and Austin offices still open? seriously? both open? Along with a Z biologics office in Austin? If Warsaw sold off Spine they would see an immediate uptick in their bottom line from unloading all those offices around the world.

    "Vacant" has had the longest tenure at Z Spine President over the last 6 years (now on at least their 4th warm body). what's up with all the folks who were hired after being forced out or canned from Stryker?

    Isn't Dvorak running out of excuses after another "goodwill" writedown ($270 million already in the last 12 months).

    Maybe it's time for TSB to get off the V Bros and take aim at the big blue Z. Or maybe Warsaw has fired a shot across TSB's bow?

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  18. 10:52 TSB is an equal opportunity employer, TSB has taken ZS to task on numerous occasions, sounds like someone has had their feelings bruised, JMHO. Would be curious to know what's going on at smaller companies like Amedica, Phygen, Custom, Atlas, Choice, Eminent, Captiva, Trans1, Sea Spine, if those companies aren't dabbling in POD's or selling direct to distributors at a discount it would be a surprise.

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  19. What a snoozer of an update. I'm going back to watching smurfs.

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  20. @ 4:29

    What's wrong with companies selling to distributors at a discount? Outside of the strange US market, that's the way the whole world works.

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  21. 7:06-Thats how the whole world works? Right, like I want to be like a frog with a cancer stick and baguette under my arm while I pay off the local inspector with promises of wine and candle lit dinners with my wife, or like a suit case full of cash to my South American counterparts to "grease the government skids" to get favorable positions with key surgeons who get the other suitcase. To be honest, capitalism may be a great thing and I am thankful for it, however the greed that exists and that which hides behind the "thats the American way" is crap. Reps are greedy and so are their bosses. And, surgeons need to stop trying to be as cool as athletes and rock stars, and be doctors. Fix people and accept the fact that you are a highly paid government employee, not Bill Gates. P.S. just cause you can afford nice suits and cars, you are still a dork and that pharma rep you are banging is just out for a paycheck too! Nerd.

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  22. 8:15
    Ha, ha, ha....What a douche bag! Frogs? really? Were you born in the 20's? Praising Rock Stars and Athletes over surgeons?
    Why don't you go back to watching Jersey Shore with your Real Doll and yelling at the TV. Life has obviously passed you by Al Bundy!

    Ha, ha, ha...Frogs! What a maroon.

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  23. Sorry Dr. if I...um I mean, 8:15 offended you. Nerd.

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  24. Nerd gettin' a hummer! Don't worry, I'll have your sister back soon. Douche!

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  25. Anybody seen the Globus Caliber? Looks like alot of titanium..

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  26. There were a lot more 510(K) approvals than what you listed. OrthoStreams had the entire list. Why is your list so short?

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  27. Eminent Spine - A spine company themed after snakes?!?! I feel like this may be some kind of a joke. How can you have a serious conversation with your surgeons while rattling off snake names?

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  28. Globus Caliber does not have a lot of Ti. Small Ti middle portion with expanding peek endplates. Pretty cool product, interested to see what kind of traction it will get.

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  29. still nothing like staxx

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  30. Expandable cages are nifty but not quite there yet. None of them provide enough graft volume inside the implant. If you want a device that is fused with a toothpick sliver of bone then you are in luck, if you want a robust bony fusion through the cage then keep looking.

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  31. Why is Synthes coming out with more Norian products, I thought they had to divest this business relationship?

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  32. Stryker is sinking the might of it's R&D budget into coming out with iPad apps.

    King Cobra... in Memphis don't they call that Malt Liquor?

    Hello Orthovita....

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  33. Robust fusion through a cage? Relying strictly on fusion through a cage makes me question a surgeon.

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  34. Orthovita joining the party a little late? WOnder if there is something up their sleeves. Doesn't seem to fit their portfolio or mission

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  35. FYI ZS has shut down OPS in Austin. Rumor has it the entire facility goes within a year. Lots of people are continuing to jump ship. Would have been better if ZS had fixed there own s*** before they bought yet another company.

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