This section highlights FDA-related milestones and regulatory updates for drugs developed by Zimmer Biomet (ZBH).
Over the past two years, Zimmer Biomet has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ROSA, iTaperloc, and Persona®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ROSA Partial Knee System FDA Regulatory Events
ROSA Partial Knee System is a drug developed by Zimmer Biomet for the following indication: Robotically-Assisted Partial Knee Arthroplasty.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ROSA Partial Knee System
- Announced Date:
- November 14, 2025
- Indication:
- Robotically-Assisted Partial Knee Arthroplasty
Announcement
Zimmer Biomet Holdings, Inc announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an enhanced version of its ROSA® Knee System that offers a more customized experience for surgeons to help deliver accurate and reproducible outcomes1 in robotic-assisted total knee replacement surgery..
AI Summary
Zimmer Biomet announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an upgraded version of its robotic ROSA® Knee System. The enhancement aims to give surgeons a more personalized, consistent approach to robotic-assisted total knee replacement by reducing user variability and supporting accurate implant placement.
ROSA Knee with OptimiZe includes five key features: OptimiZe Planning™ for customized surgical plans based on surgeon preferences; OptimiZe Landmarking™ to reduce landmarking variability; OptimiZe Tracking™ with motion-sensitive Active Track™ to keep resections on plane without pinning; OptimiZe Kinematic Alignment™ to automate resurfacing to a knee’s pre-arthritic position; and OptimiZe Experience™, a simplified interface that tailors workflow and displays. It is designed to work with the Persona® Knee System and can cut planning time on average by about 46%.
The system links to ZBEdge® Analytics for intraoperative data review. Zimmer Biomet plans a targeted release later this year with U.S. commercial availability expected in Q1 2026.
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ITaperloc FDA Regulatory Events
ITaperloc is a drug developed by Zimmer Biomet for the following indication: First Iodine-Treated Total Hip Replacement System.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- iTaperloc
- Announced Date:
- October 28, 2025
- Indication:
- First Iodine-Treated Total Hip Replacement System
Announcement
Zimmer Biomet Holdings, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's first-to-world iodine-treated total hip replacement system. This is the first product in Zimmer Biomet history to receive this designation.
Read Announcement- Drug:
- iTaperloc
- Announced Date:
- September 25, 2025
- Indication:
- First Iodine-Treated Total Hip Replacement System
Announcement
Zimmer Biomet Holdings announced the Pharmaceutical and Medical Devices Agency (PMDA) in Japan approved the iTaperloc® Complete and iG7™ Hip System, the world's first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.
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Persona® SoluTion™ PPS® Femur FDA Regulatory Events
Persona® SoluTion™ PPS® Femur is a drug developed by Zimmer Biomet for the following indication: For patients with sensitivities to bone cement and/or metal.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Persona® SoluTion™ PPS® Femur
- Announced Date:
- December 4, 2024
- Indication:
- For patients with sensitivities to bone cement and/or metal.
Announcement
Zimmer Biomet Holdings, Inc 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.
AI Summary
Zimmer Biomet Holdings, Inc. recently received FDA 510(k) clearance for its Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a new total knee implant component. This innovative component is designed specifically for patients who are sensitive to bone cement and metal, addressing a common issue that can lead to revision surgeries. The implant features a porous plasma spray coating that enables cementless fixation by promoting bony ongrowth. It is manufactured from a proprietary Tivanium® alloy, known for its long-term clinical use of over 17 years, and is treated with a surface hardening process to offer enhanced wear performance. By providing surgeons with a cementless alternative, the Persona SoluTion PPS Femur aims to reduce the risk of implant failure associated with metal and cement hypersensitivities. The product is expected to be available commercially in the U.S. by Q1 2025.
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