Otis type cutting blocks

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Anonymous said:
Uh, its not unusual for slimey companies to promote their products off label.
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Okay, please provide us with the press release or FDA posting that other companies are effected by Otismed's actions to refile their previously inadequate 510k documents. Your claims are completely false. No other company is effected.
 



Can someone from Z-corp please tell me when our matched knee is coming out! I've got three very pro-Zimmer surgeons booking Signature knees! Frustrating! I hear November, but I also hear thats not accurate. What is it?!
 


















I have heard that all the companies claim to have perfect blocks but the fit and alignment is really not perfected yet. Maybe Otis is the closest to this, but they have their problems too. Any comments from the guys selling these blocks for companies other than Otis/Stryker?

Are there any companies that make a generic Otis type block that works with every manufacturer?
 



Re: Evolution of the custom jig

I ran into very interesting alternative technology from Tekuzine LLC at the AAOS 2 weeks ago. They demoed some very neat software that planned the knee on the functional axis's of rotation based on collateral band attachment points ( this is my opinion is and always was the gold standard if you could achieve it ) And to reduce/eliminate the issue of jig slop or rocking due to mis-coupling of surface to surface ( jig to bone ) registration uniquely, they have perfected algorithms that would pinpoint best location areas to give you a unique lock using point to surface matching instead. This could become the gold standard for all patient specific, custom, shape matched technology in the near upcoming future. I talked to the CEO and they are looking for funding to take this to the next level, looks like they do have some true lateral thinkers in their group. It was nice to see evolution instead of criticism. Good work www.tekuzine.com
 



Re: Evolution of the custom jig

Anonymous said:
I ran into very interesting alternative technology from Tekuzine LLC at the AAOS 2 weeks ago. They demoed some very neat software that planned the knee on the functional axis's of rotation based on collateral band attachment points ( this is my opinion is and always was the gold standard if you could achieve it ) And to reduce/eliminate the issue of jig slop or rocking due to mis-coupling of surface to surface ( jig to bone ) registration uniquely, they have perfected algorithms that would pinpoint best location areas to give you a unique lock using point to surface matching instead. This could become the gold standard for all patient specific, custom, shape matched technology in the near upcoming future. I talked to the CEO and they are looking for funding to take this to the next level, looks like they do have some true lateral thinkers in their group. It was nice to see evolution instead of criticism. Good work www.tekuzine.com
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Howell is that you? Lateral thinking= no clinical experience. Ask Otis why the rest of the industry has taken all their business and pretty much no MD will go back to them. Also, the technology is inherently dead on arrival has pricing pressure will eliminate demand.
 



Anonymous said:
Dear Moron,
There is no FDA approval process for instrumentation. Therefore no custom instrumentation is FDA approved. That also means that normal intramedullary instrumentation is also not FDA approved.
What is the distinction of producing in house? If there is a 3rd party rapid prototype company that works with Bio/Zim that just makes Bio/Zim more efficient as they do not have to buy and develope manufacturing equipment. The turn around from plan to surgery is not effected and is quite rapid.
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Wow, are you misinformed! FDA needs to reveiw submissions on all instruments related to total joint surgery. Company needs to demonstrate or show that they are safe and effective. Claims regarding the instruments are also reviewed. If all i's are dotted 7 t's are crossed, then they allow you to market them. Instruments are often submitted with 510k's, claiming that they are substantially similar to previous instruments, but that makes it difficult to make claims of superiority.
 






Re: Evolution of the custom jig

Anonymous said:
I ran into very interesting alternative technology from Tekuzine LLC at the AAOS 2 weeks ago. They demoed some very neat software that planned the knee on the functional axis's of rotation based on collateral band attachment points ( this is my opinion is and always was the gold standard if you could achieve it ) And to reduce/eliminate the issue of jig slop or rocking due to mis-coupling of surface to surface ( jig to bone ) registration uniquely, they have perfected algorithms that would pinpoint best location areas to give you a unique lock using point to surface matching instead. This could become the gold standard for all patient specific, custom, shape matched technology in the near upcoming future. I talked to the CEO and they are looking for funding to take this to the next level, looks like they do have some true lateral thinkers in their group. It was nice to see evolution instead of criticism. Good work www.tekuzine.com
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I saw them too. I was rather impressed that they were the first to address the several key issues with why post-op alignments with first generation custom jigs occurred in the first place, and structured their process as to reduce such occurrences and they also had redundant alignment checks ( long axis ) designed into the software which is an industry's first. Oh and what I was able to get out of the demo video was that the whole process was now semi automated taking the manual labor intensive tasks out of the processes, reducing manufacturing time and costs etc. Mucho impressive indeed! And to top it off these guys seem to have put together software filters that can enhance planning etc by providing the planner with tools to visualize ligamentous structures, even had a post op simulation mode that took that knee between flection and extension with selected spacer sizes to gauge gap, sort of a hybrid between measured and gap technique fusion. I wouldn't be surprised to see more of this company in the future.
 



Anonymous said:
Recall? Exactly what has been recalled?......nothing.
FDA wants paperwork completed. NO recall.
It may be slanderous for you to use that language - you may want to get your facts straight, even if you feel threatened by the technology.
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Guess the prior post wasn't slanderous after all. Biomet/Strytker and OtisMed were making claims without any clinical justification on a medical device without approval. The product WAS NOT FDA approved and some of the patients injured by this unapproved device have suffered. All of their pain so companies and sales reps. can make an extra buck??? Shame on all of you.
 



Anonymous said:
Recall? Exactly what has been recalled?......nothing.
FDA wants paperwork completed. NO recall.
It may be slanderous for you to use that language - you may want to get your facts straight, even if you feel threatened by the technology.
Click to expand...
Guess the prior post wasn't slanderous after all. Biomet/Strytker and OtisMed were making claims about OtisMed without any clinical justification on a medical device without approval. So were the doctors and hospitals who were convinced to market this unapproved device. The product WAS NOT FDA approved 2007-2009 and some of the patients injured by this unapproved device have suffered. All of their pain so companies and sales reps. can make an extra buck??? Shame on all of you.
 



Anonymous said:
Guess the prior post wasn't slanderous after all. Biomet/Strytker and OtisMed were making claims about OtisMed without any clinical justification on a medical device without approval. So were the doctors and hospitals who were convinced to market this unapproved device. The product WAS NOT FDA approved 2007-2009 and some of the patients injured by this unapproved device have suffered. All of their pain so companies and sales reps. can make an extra buck??? Shame on all of you.
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Guess this whole OtisMed thing has finally started played itself out. How embarassing for those surgeons and company people who were involved with this questionable activity from the beginning. We should all feel bad for the patients who may have suffered.
Stryker offering only $33 million to settle this does not nearly seen enough considering Biomet has yet to comment on their involvement from the beginning. Guess we still have to wait a little longer to see the final outcome.
Will the surgeons involved in the unapproved promotion be held accountable? What about company employees?
 



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