PRECICE MAX FDA approval comes with a Caveat

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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!

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that’s what I think.

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