
FDA clears new stemless anatomical total shoulder implant from Smith+Nephew
Smith+Nephew (NYSE: SNN)+
announced that it received FDA clearance for its stemless anatomic total shoulder for the Aetos system.
Smith+Nephew (NYSE: SNN)+
announced that it received FDA clearance for its stemless anatomic total shoulder for the Aetos system.
The Osseofit devices are intended to match patients’ shoulder bone anatomy and preserve healthy bone in total shoulder replacement procedures.
WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients with sensitivities to bone cement and/or metal.
The device has sold well in Europe, where the company said it has a 60% market share, but will be the first product of its type available in the U.S.
Corin announced that it received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA).
Exactech announced today that it received FDA 510(k) clearance for its Truliant porous tibial tray, a 3D tibial knee implant.
CytexOrtho today said it has approval from the FDA to start a Phase 1 clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients.
Si-Bone today announced the first patient procedures with its FDA breakthrough device, the iFuse Torq TNT implant system.
CHICAGO, Oct. 3, 2024 /PRNewswire/ — Amphix Bio, a company developing a new class of regenerative medicine therapies, announced today it has received a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for a drug-device combination product for bone regeneration. The designation covers the use of the therapeutic device to treat degenerative disc disease with transforaminal lumbar interbody fusion (TLIF) procedures.
IRVINE, Calif., Oct. 3, 2024 /PRNewswire/ — OrthAlign, Inc., a privately held medical device company, announces FDA 510(k) clearance of their Lantern Hip handheld technology for direct anterior total hip arthroplasty with the patient in the supine position. Lantern Hip is the latest addition to the Lantern platform, joining existing applications for total knee, revision knee, and partial knee arthroplasty.