Otis type cutting blocks

Quote
















Anonymous said:
Only FDA approved and in-house manufacturered custom blocks are SN.
Click to expand...

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.
 



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.
Click to expand...

I'd be cranky too if my market share was going down the shiitter. Tough to sell that crap without a checkbook, huh.
 



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.
Click to expand...


I'd be cranky too if my market share was plummeting. Tough to sell that junk without a checkbook, huh.
 



Ive seen the zimmer blocks. Which they probally shouldn't be showing us legally. Also we looked at the signature later that day. I like them both but I'm worried that we didn't get showed the signature a year ago? Why did the rep sit on this. Is there a reason?

The signature is very medial approach which I'm ok with. Varus/Valgus could be interesting.
 



The only company that has this figured out is OtisMed right now. 30k cases under their belt(10x more than all other companies combined)....bio-compatible cutting blocks that can restore either mechanical or kinematic alignment.....custom jigs that actually take soft-tissue balancing into effect, rather than just size & alignment....peer-reviewed publications...& a huge study with unbelievable results that will be released at AAHKS in Nov.

Everyone else is playing a lot of catch up.
 



Anonymous said:
The only company that has this figured out is OtisMed right now. 30k cases under their belt(10x more than all other companies combined)....bio-compatible cutting blocks that can restore either mechanical or kinematic alignment.....custom jigs that actually take soft-tissue balancing into effect, rather than just size & alignment....peer-reviewed publications...& a huge study with unbelievable results that will be released at AAHKS in Nov.

Everyone else is playing a lot of catch up.
Click to expand...

No one offers a component that likes anatomic alignment. You can have all the short term data you want, most discerning surgeons will be laughing at the 5-10yr. failures.
 



How do you align the mechanical axis with just a knee scan? i have seen peer reviewed publications showing less than optimal results with otismed. I guess you could say everyone else is playing catchup or you could say everyone else is taking the time to get it right.
 



Anonymous said:
No one offers a component that likes anatomic alignment. You can have all the short term data you want, most discerning surgeons will be laughing at the 5-10yr. failures.
Click to expand...


*The vast majority of patients anatomic alignment falls within +/- 3 degrees of V/V

*Surgeons aren't using Otis with patients that have servere natural V/V alignment(or they shouldn't)

*Rather than blindly aiming for 0 degrees along mechanical axis(& usually not getting there)...it makes more sense, from a soft tissue standpoint, to aim for a patient's kinematic axis, from a function standpoint.

*The short term results are incredible. As long as a surgeon recognizes that using an OtisMed Kinematic shape fit knee design with a patient with high natural V/V malalignment could result in poly wear to the implant, the overall long term results should be just as good.

Also, Otis will be getting software to allow the surgeon to choose between kinematic & mechanical alignment, to handle this issue. Like I said, everyone else is playing catch up.
 



"Also, Otis will be getting software to allow the surgeon to choose between kinematic & mechanical alignment, to handle this issue. Like I said, everyone else is playing catch up. "

If there are already systems out there that allow the surgeon to choose between the anatomic or mechanical axis, doesn't that mean Otismed is playing catchup? Also, if the kinematic alignment is so great why go to mechanical alignment?

How is a full length MRI or CAT scan blindly aiming for the mechanical axis? Do you have any evidence to show the other systems are not getting there? It may be considered blindly when you only use a scan of the knee to align to the mechanical axis like Otismed is trying to do.

So basically what you are saying is that since you can't align off the mechanical axis accurately with your system then no one should. Instead of placing the implants in the best alignment and balancing the tissue, you just use the patients current alignment and claim an advantage for the patients soft tissue. A patient will walk out of a Otismed case with the exact same alignment as they came in. If the pateint has high V/V then the surgeon shouldn't use it because it won't correct the problem and will probably result in increased poly wear.

Why do I have a feeling you will soon incorporate alot of the features of the other systems and then claim they are playing catch up
 



Dear Otis:
How do you get mechanical alignment from just a knee scan? Don't you need full length ankle, knee, and hip scanning?
PS: Doesn't trying to get mechanical knee alignment go against your entire involvment in the custom knee/MRI scanned technology? Is Dr. Howell an AHKS member?

Signed,
Discerning Surgeon
 









Only FDA approved custom cutting blocks are from Smith & Nephew. FDA has ordered that all other blocks must cease to be sold until the proper documentation is filed with the FDA. Recall or no recall, call it what you want. The only blocks that can now be sold are the ones from SN.
 



Anonymous said:
Only FDA approved custom cutting blocks are from Smith & Nephew. FDA has ordered that all other blocks must cease to be sold until the proper documentation is filed with the FDA. Recall or no recall, call it what you want. The only blocks that can now be sold are the ones from SN.
Click to expand...

Really? Why do I have 5 signature knees next week and why do I have many in production? The only company efffected is Otis. They did not file their 510k correctly and are taking appropriate action. Biomet, Wright, Zimmer, and Depuy are not effected. Please try again.
 






Top Bottom
Back
Quote