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Zimmer Biomet (ZBH) FDA Events

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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.

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

  • 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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