FDA Events for 3D Systems (DDD)
This section highlights FDA-related milestones and regulatory updates for drugs developed by 3D Systems (DDD).
Over the past two years, 3D Systems has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TOTAL. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TOTAL ANKLE - FDA Regulatory Timeline and Events
TOTAL ANKLE is a drug developed by 3D Systems for the following indication: For Key Ankle Indications.
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:
- TOTAL ANKLE
- Announced Date:
- September 11, 2024
- Indication:
- For Key Ankle Indications
Announcement
3D Systems announced the Food and Drug Administration (FDA) has provided 510(k) clearance for TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew's SALTO TALARIS◊ Total Ankle Prosthesis and CADENCE◊ Total Ankle System.
AI Summary
3D Systems recently announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for its TOTAL ANKLE Patient-Matched Guides. These guides are designed to be used with Smith+Nephew's SALTO TALARIS Total Ankle Prosthesis and CADENCE Total Ankle System. Using advanced 3D printing technology and the company’s VSP surgical planning workflow, the guides are custom-made for each patient. This personalized approach allows for accurate pre-surgical planning and helps surgeons properly prepare the tibia and talus for implant placement.
The patient-matched guides aim to improve surgical accuracy, minimize the number of steps involved, and potentially reduce operating room time and intraoperative x-ray exposure. This FDA clearance highlights the growing role of personalized, 3D printed solutions in orthopedic surgery, enabling improved outcomes and enhanced efficiency for total ankle replacement surgeries.
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3D Systems FDA Events - Frequently Asked Questions
As of now, 3D Systems (DDD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, 3D Systems (DDD) has reported FDA regulatory activity for TOTAL ANKLE.
The most recent FDA-related event for 3D Systems occurred on September 11, 2024, involving TOTAL ANKLE. The update was categorized as "FDA Clearance," with the company reporting: "3D Systems announced the Food and Drug Administration (FDA) has provided 510(k) clearance for TOTAL ANKLE Patient-Matched Guides to be used with Smith+Nephew's SALTO TALARIS◊ Total Ankle Prosthesis and CADENCE◊ Total Ankle System."
Currently, 3D Systems has one therapy (TOTAL ANKLE) targeting the following condition: For Key Ankle Indications.
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:DDD) was last updated on 7/13/2025 by MarketBeat.com Staff
