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[Michael J. Assayag, MD]

Hi everyone,

I know you guys have been waiting for almost 3 years for informations about a new WEIGHT BEARING PRECICE. Please know that this information comes directly from Nuvasive Specialized Orthopedics, the company that designed the technology, and Globus Medical, the company that acquired them.

As of Friday December 15th, the FDA has given their approval for the use in a clinical setting of PRECICE MAX, however giving it only a partial weight bearing label of 50lbs across all sizes.

Although NSO feels strongly that their implant is capable of more, they will have to perform more testing  before giving it a higher weight bearing  safety factor . Just know that it will always be designated as a “partial weight bearing solution” only.

The liability of any additional weight bearing beyond 50lbs  would basically be put on the surgeon and the patients shouldersat this time, until further testing is done to allow the FDA to modify the weight bearing on label.


At this time, Globus will likely start production of the implant but it is unclear how the release to the market process will be like.

Don’t keep your hopes up, I will keep you updated every step of the way!

[NailedLegs]

Thank you Doctor!

I appreciate everything you do. Your huge wealth of knowledge is greatly needed. God bless you and your family.

[Marie_Bard]

Wow!! that's practically similar weight bearing ability with the already existing Precise! Does it mean that that FDA is not convinced.
Which makes me think why taking risks with a new and not fully tested nail (which by the way doesn't seem to be deleivering what was promised and it will be more expensive) when I can stay safe with the existing and well tested Precise??

[Michael J. Assayag, MD]

that’s what I think.

Until we have more clinical trials or the FDA accepts the weight bearing safety factor testing

[Rockstarz5]

 
  Correct me if Im wrong, FDA will said that only 50lbs and it can marketing, it sound like the precice max can load more but FDA doesnt want to said more, more like advise than actual fact in order to being recall again, is like if you have a 1,000 hp car but the goverment and the company said can only run as 80m in order to be safe,

So it can load more or in reality you can only weight 50lbs, confusef right now,

Question, ¿does the precice max material is like the stryde, gnail, betzbone or more like the precice ?

[TheDream]

How do they do clinical trials with a weight bearing nail? Are there say 10  test subjects that volunteer to receive a free paid for CLL with the new device and then they test to confirm whether it truely can be weight bearing in a real setting or is this unethical and not allowed? So maybe just testing the device in a laboratory instead?

[TheDream]

By the way just thought id mention this as it is very relevant:

Dr. Paley just released an interview with Cyborg4life adressing this. He starts talking about it at timestamp 23 minutes and 30 seconds in the following video:

https://www.youtube.com/live/i8eVt0r1xoI?si=9amUn3ezbk4x5xG9

He says the FDA has gone shy after what happened with Stryde and have cleared it for 50 lbs across all diameters, even though obviously larger diameters can bear more weight.

He says the FDA have not forbidden the use of it for weight bearing, but have attached a warning instead, saying that all doctors should warn their patients that this is the FDA approval, but as I understand he says they will use it as weight bearing.

[Lamba_Lund]

Hi everyone,

I know you guys have been waiting for almost 3 years for informations about a new WEIGHT BEARING PRECICE. Please know that this information comes directly from Nuvasive Specialized Orthopedics, the company that designed the technology, and Globus Medical, the company that acquired them.

As of Friday December 15th, the FDA has given their approval for the use in a clinical setting of PRECICE MAX, however giving it only a partial weight bearing label of 50lbs across all sizes.

Although NSO feels strongly that their implant is capable of more, they will have to perform more testing  before giving it a higher weight bearing  safety factor . Just know that it will always be designated as a “partial weight bearing solution” only.

The liability of any additional weight bearing beyond 50lbs  would basically be put on the surgeon and the patients shouldersat this time, until further testing is done to allow the FDA to modify the weight bearing on label.


At this time, Globus will likely start production of the implant but it is unclear how the release to the market process will be like.

Don’t keep your hopes up, I will keep you updated every step of the way!

I am perplexed why you ended with the negative note of 'Don’t keep your hopes up'? Dr. Paley in his interview with Cyborg clearly says that it is a weight-bearing nail, FDA had its reasons to not mark it so, are you saying you don't agree with Paley and it is not a weight-bearing nail? or do you mean to say the nail may not come out at all and that is why we should not have high hopes?

[1team]

Is it only USA that gets Precise Max in 2024 so rest of world has to wait till at least 2025?

[Kintaeryos]

• Although NSO feels strongly that their implant is capable of more, they will have to perform more testing  before giving it a higher weight bearing  safety factor.
  
• Just know that it will always be designated as a “partial weight bearing solution” only.

Why would it "always" be designated as that if there are more tests that have to be conducted?

[bruhh]

I am perplexed why you ended with the negative note of 'Don’t keep your hopes up'? Dr. Paley in his interview with Cyborg clearly says that it is a weight-bearing nail, FDA had its reasons to not mark it so, are you saying you don't agree with Paley and it is not a weight-bearing nail? or do you mean to say the nail may not come out at all and that is why we should not have high hopes?

He's just being realistic and ethical instead of looking after his $$$ like other docs using the new nail as a marketing ploy to get new patients and charge higher prices. The weight-bearing tests show that Precice 2.2 12.5mm has about the same weight-bearing capacity as Precice Max 10 and 11.5mm.