Wednesday, December 15, 2010

FDA Clearances of 510(k)s

DePuy Spine:  Modification to Expedium Spine System
Depuy Spine:  Viper Spine System
Difusion Technologies: Xiphos Interbody Fusion System
K2M: Caspian Spinal System
LDR Spine: Spinetune Titanium Ti. Spinal System
Life Spine: Small Plateau Spacer System
Medtronic: Kyphon Xpander II Inflatable Bone Tamp
Medtronic: T2 Xvbr 1.5 Spinal System
Medtronic Spine, LLC: Kyphon Anchor Facet Facet Screw System
Orthovita: Fm-02 Bone Graft Substitute
Paradigm Spine: Interspinous Fusion Plate
Pioneer: Spinous Process Fusion Plate
Pioneer: Cannulated Screw
Spinal Elements: Sapphire Anterior Cervical Plate
Vertebral Technologies Inc: Interfuse T Intervertebral Body Fusion Device

Looks like it was another busy month for the FDA.  The trend is for companies to attack the existing opportunities in the interspinous process market witness by additional products that were approved in addition to the AXLE Rose Interspinous Process Device that X-Spine recently launched.  Word on the Street is that the Guns n' Roses device has some nice features and benefits. A little marketing would go a long way for X-Spine.  If anything this device should help X-Spine.  As for Pioneer launching a cannulate screw, logic tells us that in all likelihood it will be used for facet fusions.  Spinal Elements came out of its summer hibernation from the mountains to launch another cervical plate, that should make it 367 and counting in the market.  The origins of the name could come from drinking Bombay Gin all summer, or with trace amounts of iron, titanium or chromium the color of the plate could be blue, yellow, pink, purple or pinkish in color.  With the launch of another cervical plate comes an increase in quota.  Pity those poor managers and distributors.  VTI continues to launch the spine version of Lego interbody devices.  By the looks of things, those long hot hazy days of summer are behind us as companies begin gearing up for a new decade and their annual national sales meetings.


  1. This is an OUTSTANDING list of products!! Exactly what the market needed were more cervical plates, ISP devices, extensions of exisiting screw lines & more VCF products!!

    The amount of R&D, ingenuity & sheer uniqueness to these products is simply unbelievable!!

    Too bad NASS isn't next week!!

  2. I cant believe globus isnt giving private stocks to their new sales reps... they are obviously in prime position to go public...

  3. So this is a list of all of the facet screws that have come out in the past year or so. In my oppinon this is what is wrong with our business. All of these companies have wasted time, money and energy to capitalize on a very small segment of the spine market. They are going to have to train all of their reps how to cover these cases and print all new marketing materials just to go out and maybe convert a couple of guys. Perc. facet screws are one of the hardest devices to place in spine, and to consistently place them well is even harder. The key to that is having a rep. that sells nothing but facet screws consulting in these cases and even with that, the docs are still going to struggle!



    OSTEOMED L.P. MRW K102438

    2010-07-15 FACET SCREW SYSTEM
    NUVASIVE, INC. MRW K101284


    2009-11-17 SPARTAN S3 FACET SYSTEM

  4. US SPINE javelin 4 LIFE!

  5. Any predictions for Spine in 2011?

  6. TSB, I think you are a month behind. Here are the approvals for November:

  7. X-spine is the best-kept secret in the industry. The fixcet is a great product.

  8. What is so great about the fixcet?

  9. Just looked at Fixcet, weak knockoff of the Interventional Spine screw, not even done as well as the Globus knockoff!

  10. Instrumentation is a tough sell on the Fixcet system!

  11. This is an actual question lacking all manner of sarcasm. Why would facet fixations screws be more difficult to place than pedicle screws?

    OK, now for some sarcasm... There are nearly 400 cervical plates approved for the same reason there are a tens of thousands of cell phones, automobiles, computers, etc. Many or even most have incremental improvements. Why should even small improvements be kept off the market? We would all be using brick phones if that were the mentality. By the way, if we had socialized the phone industry in the 80s like the democrates want to socialize healthcare, we would all have the relatively expensive, crappy brick phone!!

  12. Simple Question: Is it improving outcomes? Answer that question honestly, and you can be as sarcastic as you want. How much thinner can we make a plate before it breaks? How many different variations exist pertaining to locking mechanisms? Are they speeding up the procedure? If its a real improvement, I agree, especially if it is driving down the cost of the implant and improving outcomes. Minor improvements like the aforementioned designs don't justify price increases, in all likelihood they are being brought to the market because its time to bring something to the market, or you look like another stagnating company. But then the hospitals are on to this game. Most companies just cannibalize their existing portfolios anyway. Is there one pedicle screw that stands about the rest when it comes to fusion? The answer that TSB hears is, "our instruments are state-of-the art. State-of-the art is not changing outcomes. Therefore, how do you justify asking for a higher price? Because its the American Way? That's why POD's have become in vogue, small companies can solicit surgeons to increase their revenue by using another me-too product at a cheaper cost to the facility while sharing in the profits. If it was the implant, would there be any need for biologics? The implant is nothing more than a scaffold. And by the way, you should really read the annual reports from some of the largest insurance companies in the U.S. and then you would find who would like to socialize healthcare, and control it. Big business controls healthcare, not the democrats, get your facts straight, or you sound like every other reactionary. TSB lives in the real world, not the one of party politics.

  13. The problem with plates was discussed in great detail at CSRS. In fact, there was a 1/2 day workshop discussing ASD. Hillebrand reports 26% ASD at 10 years, Garvey 17% at 3 years. In addition, a rating scale was created by Riew on Ossification of ALL and adjacent levels. According to the experts, It turns out that if a plate is within 5mm of the superior or inferior disc it results in a 46% ossification rate of the adjacent level. That means that there is plenty of room for improvement TSB.

    Zeidman stated that to avoid ASD and ossification you must:

    *use the shortest plate possible

    *do not place plate >5mm to the ends of the vertebrae

    Also, caspar pin placement and screw trajectory were attributed to causing vascularity issues also resulting in ossification of the ALL and ALD. Avoid pin placement and angle screws away from the ends.

    Improvements are definitely needed. Unfortunately most companies don't try to make real improvements anymore and copy others instead. There are a few new ideas out there and fresh products, but you have to sift through the pile of copies to find them. The problem is nobody wants to think anymore.

  14. MM and 1:36PM from 11:42AM:

    Both well thought out opinions. Thank you. Another component to this whole socialized medicine discussion what most people don't admit: One reason private insurance prices are so high is that the government (medicare, medicaid) and OUS markets pay below fully burdened cost. The US private industry is simply changed more to make up the difference and pay for R&D. We subsidize the WORLD. If the US health care system were socialized, new treatments and health care advancement would come to a halt.

    MM: I agree with you about big corporate wanting to manage a socialized system. Big insurance and big pharma are government lapdogs feeding at the troth to be sure. CMS seems to lead the way though...

    1:36PM: It would appear that the stand alone cervical devices would avoid the 5mm ASD problem. True?

    Great discussions and blog...

  15. 4:36 - yes, one would think that is the obvious solution, and if our industry was predicated only on patient care then stand-alone would be the answer. But we must be realistic, the NASS coding committee has created a dis-incentive for surgeons to use stand-alone devices and has published a statement that surgeons should not code CPT 22845 (Anterior Segmental Instrumentation) for one-piece stand-alone devices. This includes a PEEK device with components i.e locking cover plate, fixation screws/staples. Nearly all stand-alone devices are not applicable. That translates to roughly $600-$800 dollars per cervical case, and as much as $1500 for a ALIF for the surgeon. When you look at the course of a year that translates into significant RVU revenues. Insurance companies have followed NASS's recommendation and are not paying 22845 for stand-alone devices, and so has the American Association of Professional Coding (AAPC). This fiscal penalty is driving some surgeons away from stand-alone devices back to cervical plates.

    Alan Crockart,MD was the invited guest speaker at CSRS last year. He told a great story about a procedure that resulted is lost reimbursement for a popular procedure in the U.K.. He stated that it caused massive revolt in Britain in the 1900's and went on to state, "Never come between a surgeon and his billing code..."

    Therefore, there is opportunity to innovate in this space and improve results.

  16. this just chapps my ass.

  17. The best cervical plate is Orion. They've tried to re-invent the c-plate for years, simplified etc. Orion still is the best. I don't even know if MSD still makes it. But, just as good as fusion rates, no screw breakage or back-out.

    So far as these new zero profiles I don't believe they work. Biomechanics are wrong and way to small of graft area.

    I think a biologic active cage or bone (vs peek) with a simple 'uni-plate' is very well good enough for the one/two levels out there.

    Multi's always will need a plate... and, I believe that if carpentry is done correctly you won't need one of the crap subsidece plates that inherently cause ASD and also have a tendency to break.

    Orion, the good old days. Who's with me... bitches.

  18. Another month and SeaSpine is silent. The product development is so slow with that company. When was their last product launch?

  19. LDR Stand Alone does not have billing issues. Its a gamechanger!

  20. What the heck is going on at Orthofix? They announce a 5% reduction in sales force and a settlement with NUVA on Trinity Evolution, effectively admitting guilt. Inquiring minds want to know. Where is the thread on that?

  21. 7:17. How do you tell a surgeon he can use 22845 when NASS recommends not to?

  22. great point 7:17 how do i become a distributor for this gamechanging ldr product and what is the commission rate? do they pay on time? is this company solid?


  24. 7:17
    The LDR is not approved as a plate and does not fit the definition that NASS came out with a couple of years ago when asked about coding for zero profile type devices. It will certainly be a "gamechanger" for your surgeon if he gets caught coding incorrectly. You need approval from the FDA (code KWQ) to truly be markeded as a plate. Most of them are approved as either an interbody device or a VBR. I think there are only one or two approved as a plate, and LDR is not one of them. All the zero profile devices (including LDR) do however offer clinical benefits over traditional plates in my opinion. Can't impinge adjacent level like an oversized plate can, and less profile if you buy the argument that plate thickness causes of dysphasia. I agree that most surgeons aren't going to pass up extra dollars by switching to these type of devices however, unless they can code them as plates. I am sure some are coding them that way, but it is risky.

  25. Sorry 8:01, Globus isn't going Public for awhile. Not in the next few years...

  26. Hey TSB - Regarding your 12:51 post, sorry, but you're looking at it from the wrong side. (You socialist! ;-)) In an efficient capitalistic market more competition, even just "me too" products, bring down prices and are an essential component of the marketplace benefiting the consumer. The more products, the better. As players enter the market, to be successful in taking share they have to add value, either by increasing benefit or reducing cost. Unfortunately, the healthcare marketplace isn't price-sensitive enough yet, so introducing an equivalent product (features, quality and service) with a lower price doesn't always get you the business. That's what is starting to change, and needs to be changed further if we want to improve healthcare efficiency.

    The fact that these extra products don't lower prices in this market has nothing to do with the fact that they are made, it has to do with the fact that they are chosen to be used, and often at higher prices, for the wrong reasons. Don't blame the product makers, blame the folks that use them despite their not adding additional value, and the system that incentivizes them to do so.

  27. A little introspective analysis would help. As one floods the market with more "me too" product, commoditization occurs. The result is less value. If I am a surgeon, why should I use your product? If I am happy with my results, if your product does not improve my outcomes, why should I change? Because it's cheaper? If that's the case, I will just leverage my volume with my current vendor and get a better deal. Remember who has the power. Besides I know who my rep is, how do I know what you bring to the table? Of course you have to blame the product makers, where is the innovation? Just because you have an idea, doesn't mean the market exists for that investment. Look at facet dowels or you honestly believe that is innovation? Example: If my plate is 2.0mm in thickness and yours is 1.9mm? What makes it better? What makes your pedicle screw better, thread pattern, self-cutting flutes, screw head angulation is it improving outcomes? If you really sell products rather than broker surgeons, explain the benefits of some of these features? Who cares if you get around a patent if your instruments suck? Who cares about a better price if I incur total aggravation from your product in the OR. As for chosen to be used? You must be kidding. Either you are part of executive management or you are young. Explain the logic behind stating; "don't blame the product makers, blame the surgeons?" What does that mean? So now its the surgeons fault that you're not innovative. Pretzel Logic at its best.

    Many small companies that offer little innovation are only looking to their surgeon investors to breathe revenue into their organizations, while they buy themselves time. Just like you're entitled to your opinion TSB is entitled to ours.

  28. TSB you're entitled to your opinion, and I'm entitled to mine that you're flat wrong. I hate to break this to you, but commoditization (if that's a word) in a mature market is a good thing for the premium paying public. It ADDS value. Commoditization means products of equivalent benefit are being produced for a lower cost. That's an increase in value. The problem is all of the things you mention: surgeons haven't been switching for lower prices or leveraging a lower price to stay with the product they are using (What's their incentive to do so?), surgeons have bought higher priced products for a feature that doesn't really add much benefit, surgeons have chosen their products based on relationships, etc., and not on value. Yes, the surgeons have been partially to blame, but it's really the system that doesn't give them an incentive to incorporate cost into their decision making. As long as that remains health care costs and our premiums will continue to skyrocket.

    Don't forget... the ability to produce and market a product for a lower cost than competitors have previously done is also INNOVATION. Just ask Southwest airlines!

    Having commodity products, those that are bought because they offer equivalent benefits at a lower price, is a crucial component of any economically efficient marketplace, and we need them in ours too.

  29. So you're really a socialist. First of all we are not selling to the public. Therefore, your point is moot. You can't go to Target to buy your implants. In addition, the Southwest Airlines example is terrible, because they fly to selective markets, i.e. profitably based on demographics, maximizing volume, and maintain low inventory compared to a major carrier. That's why they charge less. Today, the airline industry is run on a cost plus basis, passing on unreasonable baggage and weight tariffs while hedging on the cost of gasoline. I thought we were in business to maximize profits? As prices decline will you be willing to work for 5% commissions? Or, maybe you will be one of those lucky Orthofix people out of a job.

    Actually commoditization is word. When a product becomes indistinguishable from others like , i.e. cervical plates, pedicle screws, biologics etc., consumers buy on price alone, there goes the profits. How do you promote innovation without capital? So maybe it is a value to the hospital, and maybe its a value to the insurance carriers, but I doubt it is a value to someone attempting to build a company, especially an early growth stage company. The only companies that will survive will be legacy companies but they will also downsize to appease their shareholders, and kill the beast.


  30. Sounds like a great business model, let's call it Physician Owned Distributorships.

  31. So why don't we build a better plate, something that will make a difference in patient outcome. We'll call it the TSB ACPS, the first ever blog brain trust design..

  32. 11:oo - I disagree with you on a few points. First, surgeons don't pay for the implants so cost doesn't factor into their "buying" decisions. Thats part of the problem. When most consumers buy products they tend to research which products offer the biggest bang for the buck for the lowest price, afterall its there money being spent. Surgeons don't do this because they don't spend their own money. Instead, they buy what they trained on, or the products from who they like, or who pays the best consulting agreement, dinner, trip, etc. Or maybe they are ruled by their smaller brain and buy from a lovely Nuvasive Barbie Doll...Price really has nothing to do with it!

    Second, Southwest succeeded in a market dominated by bankrupt companies. How? The product that they sold was "Freedom to Travel the Country," not "cheap" airfare. Thats what Song and Ted did and we know what happened to them. Cheap ticket with the usual restrictions and penalties = bankruptcy. SW allows you to get refunds for unused tickets or allows you to have a credit against future tickets, or you can give anyone your ticket. All others force you to use the tickets from and to where the ticket was booked by the person who booked the ticket only. So in a complete commodity market SW created value where others did not. I think you make a bad comparison.

    MM - What was the last big innovation that Medtronic, DePuy, Synthes, or Stryker innovated? A cannulated screw? A dynamic plate? Posterior cervical? We all know big companies do not innovate. Innovative companies sell to big companies after they create new markets or significant buzz around a technology. Innovation always wins. Hopefully, we are due for some soon!

  33. Need I remind you that you are the one advocating that companies must innovate to bring a product to market. Regulating access to a marketplace is very much a socialistic characteristic. I am the true capitalist, as I am advocating that it doesn't matter what product you bring, if it's better, people will buy it. And yes, better does in some instances mean nothing more than it's cheaper. Of course market commoditization means less capital and profits for the industry, and right now as I'm sick of paying astronomical insurance premiums, I'd be happy to see it. The whole US healthcare industry is bloated and inefficient, with tons of goods and services being provided and used that are of questionable value to the patients and public as a whole, whom we all ultimately serve. You yourself keep saying it! We could stand to be leaned up and fitted up a bit, with the dead weight being shed. And yes the savings would first go to insurers and hospitals. They supply it on the publics behalf, so they'd save it first. But as both are highly competitive and very price sensitive industries, those savings would quickly be passed on to consumers in the efforts to gain market share. The bottom line is that if surgeons start choosing to use equivalently effective and serviced, but cheaper, ACDF plates, we all benefit. His/her professional and ethical desire to maximize clinical benefit will ensure that the plate he/she chooses will do the job. But all other things being equal, the cheaper one is the better choice.

  34. I'd like to offer my 2 cents. Deregulation did wonders for the economy, didn't it? Let's deregulate everything. When money's at stake no one wants an impediment. Let's face it both parties have failed the American public, and now everyone will pay. Contrary to what is said, I must agree with TSB, as profits decline the chances of innovation making it to the market becomes less probable. Since healthcare will be 28% of the GDP by '12, everyone will make less in this industry, and the only people making money will be the insurance industry.

  35. Re: Southwest, they absolutely did make a better product in a number of ways. But what made them truly successful was that they made flying cheaper. People didn't flock to Southwest because of their peanuts, or their younger flight attendants, or their leather seats, all of which were improvements in product quality. They fly Southwest because it's cheaper, and they even give up reserved seats, frequent flyer status, non-stops, etc. to do it. When docs have an incentive (not necessarily financial) to give up dinners, a rep in every case, Barbie doll looks, etc. to buy a product that's less expensive, but equally effective, that's when we'll have a more affordable health system.

    And don't get me wrong, innovative products are absolutely critical and the market for truly innovative products will always be there. Just don't knock the commodity products. They're playing just as an important role in the system, when they're allowed to help keep prices down.

  36. Hey 9:22

    Ever hear of the ASR Hip? I vote in favor of even more deregulation. Predicate device? I'd like to meet the doctors that were touting all those great results. Paid consultant's? Something smells like cheese. Publicly traded companies will do anything to protect its stock value. Is that associated groin pain any thing like the leg pain that patients complain about from the XLif? Patients with the ASR had elevated blood levels of cobalt and chromium? Hmmmm? Wasn't that cup approved without clinical testing? All for the Almighty Dollar

  37. Hey 3:19 - Was that marketed as a low cost alternative? (I'm ignorant about hips.) If not, it's a nice example of a bad product but has nothing to do with the discussion.

    But more importantly, that's just a bad product. Our discussion is about equivalent quality products being offered, not bad ones. TSB says you have to innovate to justify putting it on the market. I say "me too" products have their place as well.

  38. Me Too have a place, all the way in the back of the line of technology advancements. RIP, a change is gonna come.

  39. 5:21 PM: That's what she said.

  40. LDR's plating system has a separate 510k approval therefore should be able to be billed separatley????

  41. How did those two little wimpy wings on the LDR show biomechanical equivalance to a cervical plate? You must either be a moron or a liar. Are you that easily fooled by marketing? Do you believe everything marketing tells you?

    Please show the KQW from FDA clearance as an anterior plate. This shouldn't take you that long...

  42. The intellectually consistent position would be that if you believe in "pure" capitalism, then you assume that businesses make the "best" decisions, and that this is true for for-profit health insurance companies as well, and that therefore anything they chose not cover must be "inferior" to what they do decide to cover.

    Right so far?

    So, as long as you don't simultaneously complain that the insurance companies "need" to cover your products, I have no problem with your claim that an endless supply of copies are a fine example of capitalism at work... but I personally suspect that we are not experiencing "pure" capitalism, and that there are misaligned incentives to overuse and over-manufacture certain technologies regardless of their clinical utility.

  43. As for your first paragraph, sorry but you're completely mistaken. In capitalism the presumption is that both manufacturers and insurers make decisions that are in their own self interest. And that the interchange of each working in their own interest works to create an efficient marketplace.

    As for your second question, absolutely. In a capitalistic system insurers can cover and not cover what they want to. If they don't cover important things, however, then docs won't sign up for their plans, and neither will patients. So it's in their self interest to cover those things important to their providers.

  44. ... as for your latter point, you're absolutely right that there are maligned incentives to overuse products, some of them coming from the manufacturer to the doctor. But the manufacturing follows the use, not the other way around. If docs wouldn't use them, the companies wouldn't make them. You can't say that the docs put them in just because the companies are making them. They put them in because they think they're necessary (good reason) or they get paid more (bad reason).

  45. This is specific to people comparing 400 cervical plates to other areas of innovation: The difference is that 400 c-plates are paid for by medicare and insurance, over-hyped by physicians who are paid royalties for these products (the hype is especially true for single-level fusions that have a high success rate regardless of what we do), and priced so that distributors get 30% and sales reps make more than some of the physicians. I'm a fan of innovation, just not on my tax money. We worry about rising health costs, yet how many of us justify selling a plate that costs $20 to make for $800 plus $500 worth of screws and disposables? That is pseudo capitalism, and a form of corruption that hurts our pocketbooks and puts patients at risk for surgeries that they don't need simply to justify a lack of creativity and business savvy in the industry.

  46. Globus SP-Fix has both a titanium and PEEK barrel assembly...I read the CEO's comments on the X-Spine web site "The proprietary modular design of the AXLE system allows for different types of inserts to be placed in the interspinous space. Surgeons can now decide if polymer or titanium is best choice for their specific needs and indications"...TSB has before called bullshit on all the "Me too" products. Why not now?

  47. where do you find the history of spinal usa hardware failure and screws backing out--some how it looks like it is being concealed from the public--who is responsible

    1. I wish I knew that too. I experienced hardware failure with screw backing out within 15 days of the original surgery. Had to have revision surgery and now am left with a paralyzed left vocal cord. I asked for a copy of the evaluation since their representative was there and sent it to them and was told it was unlikely since they are so big I would ever get it.