The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the combined use of two surgical planning and patient specific instrument sets for ankle surgery.
3D Systems, Inc., based in Littleton, Colorado, submitted the devices for 510(k) clearance. The ankle arthroplasty implantation systems were cleared for use with certain Smith+Nephew systems.
According to the FDA’s summary document, the Cadence Ankle PSI System is “intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting.”
Furthermore, the Cadence Ankle PSI System is “intended for use with Smith+Nephew’s Cadence Total Ankle System and its cleared indications for use.” The combination of the surgical guides and instruments “facilitate the positioning of Cadence Total Ankle Prostheses.”
Moving to the Salto Talaris PSI System, according to the FDA’s summary document, it is “intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting.”
The Salto Talaris PSI System is also “intended for use with Smith+Nephew’s Salto Talaris Total Ankle System and its cleared indications for use.” When used in combination, the surgical guides and total ankle system, “facilitate the positioning of Salto Talaris Total Ankle Prostheses”
In order to qualify for the shorter and earlier 510(k) clearance medical devices must be substantially equivalent to a predicate device. Here, both systems have the same indications for use as the predicate device, Vantage® PSI System, an ankle arthroplasty implantation system. According to FDA document, the only change is “the orthopedic implant that the patient-specific instrumentation is guiding.”
Mark McMahan, the vice president of marketing, global orthopaedics at Smith+Nephew, expressed excitement about the partnership, saying, “We are excited to partner with 3D Systems and unveil our new TOTAL ANKLE Patient-Matched Guides for total ankle replacement—a breakthrough to help transform the way healthcare professionals approach surgical precision and improved patient outcomes.”
McMahan continued, “This advanced system is designed to offer unparalleled efficiency and accuracy, ultimately enhancing the overall experience for both surgeons and patients.”
