Custom-Fit Total Knee Replacement
The latest marketing of patient-specific implants has led manufacturers to develop custom cutting guides and even custom implants for both sexes. There are real economic constraints to these options and many question their basis given evolving scientific reports of no difference in outcome when compared to meticulous surgical technique and planning. I have always believed that the best outcomes are realized with surgical strategies to achieve a custom-fit total knee replacement by standard implant technique to be a better option. Now, we learn that the CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies’ personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.
FDA Targets Personalized Knee Surgery Systems With Warning Letters
CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies’ personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.
Johnson & Johnson/DePuy received a letter dated Aug. 19 from the FDA device center suggesting that the company is illegally selling its TruMatch Personalized Solutions system without PMA or 510(k) go-ahead.
Biomet was the subject of a July 27 FDA letter, posted online Aug. 17, making the same charge for that firm’s Signature personalized patient care system.
Both letters resulted from reviews of the companies’ websites by CDRH Office of Compliance officials.
The TruMatch and Signature systems are offered to surgeons that use knee replacement devices manufactured by the respective companies.
Surgeries using the systems require an image be taken of a patient’s knee to construct a three-dimensional model. The company uses the model to fabricate custom femoral and tibial cutting guides for use during the patient’s total knee replacement procedure. Biomet’s system employs computed tomography or magnetic resonance imaging, while DePuy’s specifically relies on CT. Marketing hype and added expense without better outcomes? Only time and clinical outcome studies will tell. The real advantage of these patient specific cutting blocks is the standardization of the knee replacement, not customizing it. By eliminating wasted time during a procedure and between cases and minimizing instrumentation there is more efficiency in the operating day.