Monday, August 23, 2010

510(k)s for July

For those of our readers that haven't seen the most recent list of 510(k)s approved for the Spine Industry here they are;

** Denotes Summary Available from FDA

Aesculap S4 Cervical Occipital Plate Spinal System**
Sibd Spinal System

Allure Spine Spondylos Spinal Fixation System **
ATEC Anterior Lumbar Plating System**

Biomet Spine: Gallery Laminoplasty Fixation System**
Blackstone Medical: Firebird Spinal Fixation System**

Dio Medical (Korean) Fixpine II System**

Genesys Spine: TiLock Pedicle Screw System**

K2m: Aleutian Ibf System** (Spacer System)

Medicrea: Impix Lumbar Interbody Device**

NuVasive: Facet Screw System**

Spine Smith Partners: Spinesmith Cynch Spinal System**
Spineart: Juliet Ol**
Spineart: Romeo Posterior Osteosynthesis System**
Stryker Spine: Modification to Radius Spinal System**


46 comments:

  1. That's great! Another great big pile of identical interbody and fixation devices.

    I can't understand why people are saying Spine hardware is becoming commoditized.

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  2. Although it's limited, Synthes released their new pedicle screw....MATRIX.

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  3. matrix is a very nice and comprehensive system, they will do well with this one.

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  4. Is Matrix a percutaneous system?

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  5. synthes is stuck in the matrix and cant get out

    stick to trauma before zimmer kicks your butt too

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  6. What is the Matrix? Only Morpheus and TSB know for sure. It's impossible to deprogram all the little Neo"s at Synthes. Besides Trinity would have to worry about being groped by management.

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  7. Someone has an obvious disdain for the #2 spine company. I'm interested to know if this product will succeed?

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  8. Allure Spine? Who came up with that name?

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  9. The average spine rep at Synthes will not be able to get their hands on this set for a year or more.

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  10. How about Spineart...Romeo and Juliet? Who is naming these systems?

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  11. They still do things the same way that they did them twenty years ago. By the way there isn"t anything tempting or attractive about Allure Spines product portfolio.

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  12. Some English major hired as a product manager. Romeo, oh Romeo where art thou Romeo? Hee I iz Stymie

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  13. Anonymous 7:03,

    I guess Julia Eller came up with that name, and she got $3,737,371 in govt contracts for 2009. Not too shabby...
    http://www.governmentcontractswon.com/department/defense/allure-spine-806985482.asp?yr=08

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  14. Interesting. Not bad for a single pedicle screw system.
    http://www.fedspending.org/fpds/fpds.php?&parent_id=387374&sortp=u&datype=T&reptype=r&database=fpds&detail=2

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  15. The real question is 'Are 510k's getting getting more difficult to clear?'. Doesn't seem so yet.

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  16. How deep do you think FDA has to dig into a "new" hardware system that is essentially identical to dozens of other systems except for the color of the anodizing?

    The FDA is transitioning (or has already transitioned) to a new 510(k) process with additional scrutiny on anything that's novel or presents clinical or technical unknowns.

    Traditional spine hardware doesn't qualify. A screw is a screw unless you're going to put it somewhere new or claim it does something screws haven't been claimed to be doing since before 1976.

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  17. The Matrix was in PD for years--I know they had manufacturing problems. Hopefully they finally ironed them out. Ironically the Matrix (assuming it hasn't changed much since I saw it) is "good" because it's back to the basics in comparison to Click'x and (gag) Pangea.

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  18. @5:09 Bullshit traditional hardware doesn't qualify. A "screw is a screw" as long as it isn't cervical/transarticular. And a cage is a cage as long as it meets the completely non-anatomical loads the FDA requires you to meet. Am I bitter? sometimes.

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  19. What's the story with the Nuva facet system? The old one had a big washer on it. What does the new one look like?

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  20. NuVa's new facet system cures cancer and sleeps with hot Asian chicks!!

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  21. If that's the case, we all wants a piece of Chicken Flied Lice.

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  22. you yanks would not know what to do with asian chick!!!!!!!!!

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  23. Yeah, but us southern gentlemen sure do!

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  24. This comment has been removed by a blog administrator.

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  25. Kevin Dunworth and Spine Smith finally got their peek cage with a string attached approved. Where is Jay Jones now and who will Kevin pay to use it?

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  26. A bit off topic but do you think this product from a medical consumables company in India will ever get approved?

    I hope not! LOL

    http://www.adleylab.com/cproduct.asp?id=7

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  27. @anon 12:07

    Last I heard, Jay Jones is/was at Pioneer.

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  28. TSB, why are you so bitter? Did management refuse to grope you?

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  29. Posting the most recent 510(k)s makes TSB bitter? Your commentary makes absolutely no sense. Maybe you just don't understand, TSB is quite happy and likes where TSB is at. Maybe you need to do a bit of house keeping on your own state of mind. Don't spend too much time analyzing TSB, 'cause I'm not losing any sleep over you.

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  30. off topic, but if you were in Michigan what spine company would you want to work for? due to managers? market share? pipeline? avg tenure? etc? thanks a bunch gentlemen, i am in the ortho world and want in!!!

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  31. Interestingly enough, TSB noticed that Medyssey, a Korean based company is preparing for their commercial launch of another pedicle screw system. Another pedicle screw system? Just what the market needs. TSB could understand launching this in Korea, but the U.S.? Based on the usual declaration of propaganda, you know, versatile system offering 5.5, 6.0 and 6.35mm Rods, dovetail joint set screw, and reverse trapezoid thread design, what is it about this screw that makes it so unique, that it is going to improve outcomes? TSB understands that we live in a free-market economy, yet, another pedicle screw with the intention of launching interbody devices as a compliment to the system? And our readers don't believe that we are euthanizing, I mean commoditizing ourselves to death. Let's get serious. Anyone in the surgeon brokering business, line up, I bet that there are deals to be had.

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  32. 9:39
    I almost agree with you but Cheney and Halliburton was a conflict of interest. Guess who won the major contract in Iraq while Cheney was in office? I view POD’s as the new Wal-Mart by capitalizing on an already commoditized market. This could be another opportunity why the Koreans are taking a stab. Plus, there is no way “POD’s or Koreans” will stay in business once they start diving into R&D. Ha! Why do you think the guy on side of the road sells oranges? Because he thought he can reinvent the strawberry!

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  33. TSB, you said "It's impossible to deprogram all the little Neo"s at Synthes. Besides Trinity would have to worry about being groped by management."

    Not only are you disingenuous for denying your bitterness a few posts later, but your tone is fairly convincing evidence that you and Rick Gennett's cyberstalker on cafepharma are the same person.

    Cue TSBs denial...

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  34. Wouldn't waste my time, nor put negative energy into chatting about a parasite.

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  35. PS: Besides, I have my own blog site, why would I need Cafe Pharma (duh) to slam someone, when I could do it right here. Have you ever read a post about him on this blog spot?

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  36. Anonymous 3:05

    You must be some Synthes dweeb that does not have anything better to do than to spout off the same non-sense you post on CafePharma. Do all of us a favor, if you do not have anything constructive to offer this blogspot go spew your BS on CafePharma. And I thought Stryker was thin skinned.

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  37. Well, what about Alphatec's new stem cells that they are peddling? Any opinions or feedback regarding? Read that it's adult derived, very vague press release on it.

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  38. Can anyone track down any details on this?

    VertiFlex®, Inc. Announces Sale of Percutaneous Fusion Portfolio

    http://www.opnews.com/popup.php?page=http://149.6.184.82/cgi/NGoto/2/441460941?4929

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  39. http://www.exac.com/news/exactech-acquires-minimally-invasive-spine-reconstruction-portfolio

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  40. Hmmn, wonder why a spine company would "spin off" one of their products to another? Gee Wally, why?

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  41. Hey Squirt, we were selling so many of those S'Bolts, and because we just could not keep up with all the orders we want to sell it all to you as we are your buddies.

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  42. It was like an info-mercial. And not only that, look, we will give you our office furnitur, too!
    However, now that Sourpuss (Moti) and Shrek(Keegan) are out of the picture that product might actually sell.

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  43. What about a 510(k) product that was approved for the cervical and thoracic but is being used in the Sacrum? Isn't this off label, or is this a normal practice?

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  44. Can the Synthes ARCH Fixation System be used for a Sacral Laminectomy??

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  45. anybody know any medical device with slit and central load bearing ball...to be used in intervertebral disc

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