FDA Events for Zimmer Biomet (ZBH)
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
Persona®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Persona® SoluTion™ PPS® Femur - FDA Regulatory Timeline and 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
Zimmer Biomet FDA Events - Frequently Asked Questions
As of now, Zimmer Biomet (ZBH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Zimmer Biomet (ZBH) has reported FDA regulatory activity for Persona® SoluTion™ PPS® Femur.
The most recent FDA-related event for Zimmer Biomet occurred on December 4, 2024, involving Persona® SoluTion™ PPS® Femur. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Zimmer Biomet has one therapy (Persona® SoluTion™ PPS® Femur) targeting the following condition: For patients with sensitivities to bone cement and/or metal..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NYSE:ZBH) was last updated on 7/10/2025 by MarketBeat.com Staff
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