We have identified the endpoints we’re looking for. They will largely relate to atherogenic injury. We’re pushing for a six-week follow-up, which is pretty aggressive. We’ve already identified the sites, we’ve already identified the CRO, we’ve identified the PIs, identified the distributors. So, this would be at a significantly reduced cost to what it would cost for us to run a clinical trial in the United States. So, the plan is if we submit the 510(k), which we think is a very, very strong 510(k) with very good equivalence arguments, but if the FDA were to come back to us and say that they had an unfavorable view of our submission and would like to see clinical data, our plan is to have it very well, far along in parallel kind of as a belt-and-suspenders where we could just say, okay, well, here it is.
And in April, we hope to fully derisk the FDA’s view on the clinical data submission. So, I hope that makes sense. We’re really trying to have optionality. And if the FDA were to approve the 510(k), it’s still fine because, first of all, the cost to run this trial is not very significant. I mean certainly, there’s cost there, but it’s much less costly than in the U.S. And then we could use that data for post-marketing post-launch marketing in the United States, and we could look for other endpoints like learning curve, accuracy of our system, surgical time, and so forth. And then we would have the added benefit of being able to launch OUS in what we think is a very attractive market. So, it’s kind of a win-win and killing two birds with one stone.
So, I just kind of want to give folks a little bit of a view of how we’re thinking about just the market generally. And Doug, this is where I’ll tee you up in a second here, but when we started, this is like very simply what we saw the market opportunity is. If you just look at the market dynamics today, there is one company that has 89% market share in orthopedic robotics for knees and 75% market share in press-fit needs. Now, in anybody’s definition of a monopoly, this is what a monopoly looks like. And our investment thesis was — is very simple. We think that not all — certainly, Stryker is a well-diversified business, but we think that Mako has added billions of dollars of value to Stryker. It’s reflected in how the stock has performed.
It’s reflected in the market performance of Mako versus everyone else. And so we think there’s a very simply an opportunity for a compelling robotic system. And we really are thinking about it in a very similar terms. That’s what we see as the opportunity. We think there’s an obvious market. It’s a very high-margin market. And we think that our investment thesis going in was that this would be valuable to somebody. Could we be wrong? And could this be a complete not valuable? Certainly. But we’re not — I don’t think that’s where we as a management team are today. I think we have a very compelling product. We think it’s competitive with the current state-of-the-art. We think that it enhances on the current state-of-the-art. And we certainly think that with future upgrades that Doug will get into like the mVision navigation, Kamran can describe as well, it will be hopefully a pretty significant improvement over time.
So, I’m just going to play this video, Doug, it’s like a two-second video here. And I want you to try and explain this because I think it really is — sets the stage for how early this market opportunity is and how significant it could be. We want to play this video. [Video Presentation]
Benjamin Sexson: I’m going to press pause here. This is from a — it’s on our site when we released an update on mVision navigation, we had a Q&A, and this is Dr. Adler describing basically why robotic adoption has been slow. And this is a big part of investment thesis. So, I’ll play and then, Doug, maybe you can comment on it.
Doug Unis: Sure. [Video Presentation]
Benjamin Sexson: So, Doug, what does that mean? I want to make sure folks understand that.
Doug Unis: Yes, I want to be careful to stay out of the weeds, so Ben, just pull me out if I go in too deep. But we’ve been doing knee replacements for 50 years with mechanical instruments, basically, that look like the kind of instruments you would use to build a chair. They’re really just jigs and saw guides and that kind of thing. And largely because — and you can imagine, that’s fairly crude. You can’t make a cut that’s 3 degrees or 2.5 degree, you can kind of cut it right angles. You can see that and judge that with manual instruments. But you can’t really make these little fine-tuned cuts. And so partially because of the constraint of the way we’ve done knees for the last few decades, every knee gets put in essentially straight so that what we call mechanically aligned knee.
So, that — and the problem with that is that very, very few people actually have their knees lined up that way. And so about 20% of knee replacement patients don’t love their knees. And so a few years ago, probably about 12-ish years ago now, there was a move to align people’s knees more the way that their individual anatomy is because we’re aligned in all kinds of different ways. Some people [Indiscernible] knee, some people are a little bit bowlegged, and there’s been more and more research looking at kind of the spread of how people are aligned. The problem — one of the problems with giving people back their kind of the way that their knee should be aligned is that to do that with manual instruments is hard. And most surgeons can’t really do it.