OTISMED RECALL

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All custom cutting guides / drill guides that do not have FDA approval are being withdrawn from market till they do.

Who has FDA approval SMITH AND NEPHEW. Who has the best system out SMITH AND NEPHEW. If you compare feature for feature plus they actually come sterile packed and can be flashed multiple times there is no question it is the most solid system (only) currently available after today.
 


The bottom-line with knees, or any prosthesis, and any reasonably mature ortho rep knows this, that every knee on the market will do well, that outcomes today are largely dependent on choosing an appropriate implant for the appropriate patient, with a reasonably skilled surgeon that properly places the component to reproduce normal or near-normal knee anatomy so patients can return to activities of daily living.

Whether the surgeon trys the signature blocks, the otis blocks or visionaire blocks, their all nothing more than external alignment guides; thats it. One knee system isnt going to out-perform another and one external alignment guide isnt going to out-perform another that translates into lessening healthcare expenditures or improving 15-year outcomes of already published conventional knee replacements when placed properly in appropriate patients by competent surgeons. Pre-planned external alignment guides offer, for the most part, a smaller margin or error, for mal-alignment of implants. End of story.
 


The Wright Medical custom cutting blocks are better than the Smith and Nephew blocks when you look at them feature by feature. The last poster is correct. This technology is a means to decrease the margin of error in component alignment. The hope is that a surgeon can more accurately reproduce the desired alignment for every case. There is also the decreased OR time that comes once a surgeon gets comfortable with using the blocks. This technology will hopefully allow every surgeon the ability to get the most out of the implants. This technology is not magic and can't overcome in shortcomings in the implant design or survivorship.
 


Anonymous said:
All custom cutting guides / drill guides that do not have FDA approval are being withdrawn from market till they do.

Who has FDA approval SMITH AND NEPHEW. Who has the best system out SMITH AND NEPHEW. If you compare feature for feature plus they actually come sterile packed and can be flashed multiple times there is no question it is the most solid system (only) currently available after today.
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Actually, Biomet, Depuy, Wright, and Smith & Nephew all have 510k approval for a MRI/CT based knee navigation. Smith and Nephew still has the worst poly in the business. I have 3 in my briefcase that were Journey retrievals that all yellowed and oxidized prematurly. I think we will see big problems for bi-cruciate design.
 


Anonymous said:
Actually, Biomet, Depuy, Wright, and Smith & Nephew all have 510k approval for a MRI/CT based knee navigation. Smith and Nephew still has the worst poly in the business. I have 3 in my briefcase that were Journey retrievals that all yellowed and oxidized prematurly. I think we will see big problems for bi-cruciate design.
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Do they all have Class 2 clearance? I think not. The FDA is looking at all the above companies and will soon require each of them to re-file as a Class 2 device. All of the above companies followed OtisMeds 510k submission and went after the same Class 1 designation because it pushes through faster. I hear that the FDA will be raining down on each of the companies above ... and soon, very soon.
 


I have been a joint rep for 10 yrs. What I have learned is all the companies have great stuff. We can't all have everything in our bag. But if you are an excellent salesman that has all the qualities it takes to become successful, then you will be! A good salesman sells what he has to work with and does not put down the competition because that is simply lame and immature. I represent a smaller company but I do over $3million a year is sales in my territory without the "big company" name to help me along.
 


Anonymous said:
All custom cutting guides / drill guides that do not have FDA approval are being withdrawn from market till they do.

Who has FDA approval SMITH AND NEPHEW. Who has the best system out SMITH AND NEPHEW. If you compare feature for feature plus they actually come sterile packed and can be flashed multiple times there is no question it is the most solid system (only) currently available after today.
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I'm curious as to how many have been implanted & what, if any, peer-reviewed articles exist to back up your claim.

Honest question.
 


Anonymous said:
I'm curious as to how many have been implanted & what, if any, peer-reviewed articles exist to back up your claim.

Honest question.
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Honest Question, but rhetorical none-the-less. The answer to your question is none. And the question needs to be adjusted to include the term 'long-term'. Just because something is peer-reviewed, doesnt mean it's effective.

Just as the answer would be the same if asked of any other guide, and the majority of knee designs on the market. Just because designs are 'variations' on a similar theme, doesnt innately make them effective. Im not the guy above, but he's perhaps a younger sales fanboi or delusional inside company man.
 




Anonymous said:
My understanding is that Oris has broken away from its relationship with Biomet & that Stryker is close to purchasing OtisMed & that is why Biomet has been working very hard to bring the singature knee system to market. IMO, The Biomet Vanguard is probably the 2nd best TKA system on the market right now, behind Stryker Triathlon. I have a high volume surgeon that has used different designs from all 4 of the major comapnies, & in his opinion, it goes:

1. Stryker Triathlon
2. Biomet Vanguard
3. Depuy Sigma
4. Zimmer Nexgen

His only real complaint with the Vanguard has to do with instrumentation & the funky locking mechanism on the tibia. I should be fair & say that the surgeon I am discussing is a big believer in single radius femoral design as a characteristic that allows for better mid flexion stability, as well as preventing paradoxal anterior translation of the femoral component.
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I guess the above super surgeon who speaks for all orthopods is NOT affiliated with the UK, Swedish or Australian registries which refute the above BS. Nexgen least revised PERIOD!!!!
 










Logic and Reason said:
Do they all have Class 2 clearance? I think not. The FDA is looking at all the above companies and will soon require each of them to re-file as a Class 2 device. All of the above companies followed OtisMeds 510k submission and went after the same Class 1 designation because it pushes through faster. I hear that the FDA will be raining down on each of the companies above ... and soon, very soon.
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I'd like to get a clear answer on this. I have heard that, for whatever reason, the FDA is not making these companies re-submit as class 2.
 




Anonymous said:
Nothing is being re-called, moron. FDA has asked OtisMed to re-submit as a class 2 device with the FDA, & until the ppwk is in order, has told Otis to suspend production of cutting blocks.

Don't worry, it will have 510K shortly & will continue to totally kick the crap out of signature, tru-fit, etc...etc...
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Almost a year now....shortly?
 


Sounds like you are all still in Kindergarten. Cutting blocks aren't even needed with Robotic PKA surgery. You can't speak of "custom" or "alignment" until you have seen this technology.
 


OtisMed was not FDA approved for use in the USA from 2007-2009. Biomet and Stryker were co-marketing a non-FDA approved medical device with the OtisMed staff. That is why the FDA had them stop marketing the device. Also, the claims being made by OtisMed were pulled due to a lack of supporting data for their claims. Everyone involved in selling and promoting non-FDA approved devices are in violation of the law. Standby and watch what happens.
 


there are still no prospective, randomized, blinded studies for otismed versus conventional knee replacement. And then there is no published data for the cost ratio .
And its only for CR knees ??? Most docs do PS these days.
All marketing and no science !
 



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