The Growth Channel

It's all in the hips: FDA approves MAKO robot for total hip replacement

By Cynthia Tassopoulos

At this year’s AAOS conference, news broke that Stryker received FDA clearance for new enhancements for the total hip arthroplasty application of its MAKO Rio surgical robot. Stryker, which acquired MAKO in December 2013, touts that the application improves upon manual acetabular cup placement by using a detailed pre-surgical planning process with the patient’s CT scan to improve implant alignment and placement.

FDA approval highlights expanding MAKO portfolio

Wait a minute, you ask. Haven’t surgeons already conducted MAKO-assisted total hip replacements over the past few years?

Yes, MAKO-assisted total hip replacements themselves are not a new development. However, the announcement does highlight an important expansion in the MAKO portfolio, specifically Stryker’s efforts to marry its orthopedic implant business with its robotic technologies.

In Stryker’s press release, they note that the MAKO system “will be compatible with a surgeon’s Stryker implant of choice,” including its top-line components. This gives physicians more flexibility in their implant selection – granted it’s within Stryker’s portfolio – since physicians previously could only use MAKO-specific implants.

Let’s review how this news impacts your program’s take on MAKO.

Making the case for MAKO & hips

New opportunities on the line
FDA approval for total hip arthroplasty creates new opportunities for hospitals to enter the orthopedic robotic surgery game.

Expands MAKO value proposition

  • The updated THA application and the newly compatible Stryker implants may allow physicians to integrate the platform more into their surgical practice.

  • Value may even further expand if the FDA approves Stryker’s proposed total knee application, although the timeline for this approval is uncertain.

Boosts hospital reputation as advanced provider

  • Programs can specifically leverage the updated THA application in marketing messages to generate community interest and awareness in the new capabilities.

Careful consideration still required
While the new application may raise MAKO’s appeal, hospitals should consider potential roadblocks to successful implementation.

Requires sizeable upfront investment

  • Providers interested in purchasing the THA application face an additional expense on top of the MAKO robot’s already high cost.

Demonstrate long-term clinical outcomes

  • The orthopedic community still lacks clinical studies that evaluate the long-term outcomes and benefits of MAKO-assisted surgery compared to the traditional approach.

While it still remains to be seen if this news will lead to a large uptick in MAKO robot adoption, the announcement signals an exciting development for orthopedic robotic technology at large. Keep an eye out for movement in your market.

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