Mako’s New Hip Application FDA Cleared

Stryker Corporation’s Mako robotic system has a new clearance from the FDA for a total hip replacement application.

The company announced the clearance and launched the hip application on March 25, 2015 at the 2015 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in Las Vegas.

The Mako system, according to the company, will be compatible with Stryker’s Accolade II, Secur-Fit Advanced, Anato and Exeter femoral implants coupled with the Trident Acetabular system and engineered X3 polyethylene.

Accuracy and Precision

A recent study cited by the company found that manual acetabular cup placement, “fell within the acceptable safe range only 50% of the time. Robotic-arm assisted total hip arthroplasty has been shown to provide excellent accuracy and precision with regard to planned cup position, leg length, and offset. Additionally, robotic-arm assisted total hip arthroplasty has demonstrated acetabular cup placement four times more consistent to the pre-operative plan than manual cup placement and significantly higher modified Harris Hip Scores and UCLA Activity Level Ratings compared with manual total hip arthroplasty at one-year follow up.

“Transform” Joint Reconstruction Surgery

Bill Huffnagle, president of the company’s reconstructive division, says combining the robotic-arm technology with the company’s implants reflects the company’s “conviction” that this technology will transform joint reconstruction surgery.

According to the company, over 50, 000 Mako procedures have been performed since 2006, with the first total hip procedure performed in 2010. Since then, over 7, 000 total hip procedures have been performed with the Mako system which facilitates various surgical approaches including direct anterior, postero-lateral, and antero-lateral.

Patient-Specific

The robotic-arm assisted total hip arthroplasty uses the patient’s CT scan data to reconstruct the anatomy and create a patient-specific surgical plan for “optimal implant alignment and placement.” During surgery, the company says the patient’s hip joint is registered and matches with the surgical plan to provide dynamic information. Robotic-arm guidance, 3-D visual feedback, and real-time data assist the surgeon.