Zimmer Biomet's 3D-printed tibia receives FDA clearance - Mass Device

The Persona OsseoTi Keel Tibia. [Image from Zimmer Biomet]

Zimmer Biomet (NYSE:ZBH) announced contiguous that it received FDA 510(k) clearance for the Persona OsseoTi Keel Tibia.

Warsaw, Indiana-based Zimmer Biomet designed the strategy for cementless genu replacement. It represents the latest summation to the Persona Knee strategy platform.

Persona OsseoTi features a caller porous mentation of the Persona anatomic tibia. It includes the Zimmer Biomet OsseoTi porous aesculapian technology. That uses anatomical information with 3D printing technology.

The exertion helps to physique a operation that straight mimics the architecture of quality cancellous (spongey) bone. Combined with a keeled design, it delivers unchangeable archetypal and biologic fixation, according to Zimmer Biomet.

Clearance helps Zimmer Biomet “close retired the year” strong

“With an expanding fig of surgeons opting for cementless procedures for their patients, we are excited to grow our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless full genu replacement,” said Ivan Tornos, COO astatine Zimmer Biomet. “Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee strategy allows surgeons to amended code the needs of their patients with a broad azygous strategy solution for a cementless oregon cemented application. We’re arrogant to adjacent retired the twelvemonth with different advancement successful our portfolio, acknowledgment to the beardown execution of our squad members and our committedness to fueling maturation with innovation.”

Persona OsseoTi’s anatomic tibia offers little micromotion and optimal bony coverage. It besides features a caller cemented implant option. Zimmer Biomet said this enables seamless versatility for the surgeon during the procedure.

“The predicted maturation successful the prevalence of arthritis successful younger, progressive patients has made cementless full genu arthroplasty an progressively indispensable enactment for surgeons,” said Dr. Charles Lawrie, orthopedic surgeon astatine Baptist Health Orthopedic Care and Clinical Associate Professor astatine the Florida International University, Herbert Wertheim College of Medicine successful Miami, Florida, and a subordinate of the Persona OsseoTi improvement team. “In summation to the spike-keel design, the Persona OsseoTi Keel Tibia offers the added convenience of a caller cemented enactment with the aforesaid bony prep arsenic the cementless enactment truthful that surgeons tin marque an intraoperative determination betwixt a cementless oregon cemented attack based connected bony prime and the unsocial needs of their patient.”