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
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.
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:
- 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.
Read Announcement
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.
Read Announcement
