Stryker took its time introducing its robotic-assisted total knee arthroplasty application for its Mako system. Now, within seven months, the company launched that system and landed FDA clearance to use it in cementless total knee replacement procedures.
Cementless total knee arthroplasty enjoyed early adoption, only to lose it over joint loosening due to micromotion, according to an article in the Annals of Translational Medicine. Stryker turned to 3-D laser printing of porous titanium components that mimic bone surface and encourage bone fixation.
“That's good for the patient,” Stuart Simpson, president of Stryker's joint replacement division told MDDI Qmed. "It should be good for long-term outcomes and make sure that [the] implant stays fixed in the patient for a very long time."
Cementless total knee replacement also appealed to surgeons for younger, more active patients who typically have healthier bones, higher expectations, and a longer life expectancy, Simpson said.
“But we’re finding with surgeons having had success with those patient types, they're starting to view it as an attractive option for more and more patients,” he said. “They’re recognizing operating efficiencies, and that outcomes are better for more patients, not just the young, active patients.”
With cementless procedures making a comeback, Stryker decided to combine its Triathlon Tritanium cementless tibial baseplate and metal-backed patella components with its Mako Total Knee system, both previously FDA approved and used independently of one another. The combination provides surgeons with a more predictable surgical procedure, increased operating room efficiency, biologic fixation, and an alternative to bone cement, according to the company.
Mako, which Stryker acquired in 2013, was designed for partial knee surgeries and then for total hip surgeries. The company launched its total cemented knee application for Mako in March and has been working with FDA on 510(k) clearance of the cementless Mako application since then, Simpson said.
Stryker continues to collect data comparing the Mako Total Knee to a traditional knee surgery, both using the Triathlon device. These studies are looking at outcome measurements including the length of hospital stay, how soon patients return to work after the surgery, the range of motion in the knee, stability, discharge to rehab time, and patient satisfaction, the company told investors during its July earnings call.
“We’re happy that it is a long approval process,” he added. “It’s part of the quality assurance, if you like, of everything we do.”