FDA Events for Enovis (ENOV)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Enovis (ENOV).
Over the past two years, Enovis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
STAR®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
STAR® Ankle - FDA Regulatory Timeline and Events
STAR® Ankle is a drug developed by Enovis for the following indication: For non-cemented implant to alleviate pain in arthritic ankle joints caused by osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.
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:
- STAR® Ankle
- Announced Date:
- August 19, 2024
- Indication:
- For non-cemented implant to alleviate pain in arthritic ankle joints caused by osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis.
Announcement
Enovis™ Corporation proudly unveils its Scandinavian Total Ankle Replacement (STAR® Ankle), now with new e+™ Polyethylene.
AI Summary
Enovis™ Corporation has introduced an upgraded version of its Scandinavian Total Ankle Replacement (STAR® Ankle), now featuring innovative e+™ Polyethylene. Recently approved by the U.S. Food and Drug Administration, the STAR® Ankle is the first and only mobile bearing ankle system in the United States to incorporate this advanced material. The e+™ Polyethylene is vitamin E-blended, which helps resist oxidation and enhances wear resistance, stability, and durability. This blend reduces the need for remelting during manufacturing, therefore preserving the strength of the implant.
The new e+™ Polyethylene technology is expected to improve long-term outcomes for patients by maintaining consistent mechanical properties over time. Enovis’ commitment to continuous improvement is reflected in this upgrade, as the company works to deliver innovative foot and ankle solutions that offer better performance and increased longevity for patients.
Read Announcement
Enovis FDA Events - Frequently Asked Questions
As of now, Enovis (ENOV) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Enovis (ENOV) has reported FDA regulatory activity for STAR® Ankle.
The most recent FDA-related event for Enovis occurred on August 19, 2024, involving STAR® Ankle. The update was categorized as "Provided Update," with the company reporting: "Enovis™ Corporation proudly unveils its Scandinavian Total Ankle Replacement (STAR® Ankle), now with new e+™ Polyethylene."
Currently, Enovis has one therapy (STAR® Ankle) targeting the following condition: For non-cemented implant to alleviate pain in arthritic ankle joints caused by osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis..
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:ENOV) was last updated on 7/10/2025 by MarketBeat.com Staff
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