3D Systems Expands Orthopedic Surgical Planning Portfolio, Receives FDA Clearance for Key Ankle Indications Page 1

• The new TOTAL ANKLE Patient-Matched Guides are paired with Smith+Nephew’s Total Ankle Replacement solution, which is designed to help surgeons save time and ensure accuracy while requiring fewer steps than standard instrumentation.
• FDA clearance extends 3D Systems’ leadership in supporting orthopedic surgeons, with surgical planning experience now exceeding 175,000 cases
• 3D Systems designs and manufactures custom, patient-specific orthopedic solutions using its VSP surgical planning workflows, which incorporate leading medical 3D printing technologies
• Advances the company’s strategy to accelerate expansion into orthopedics through 3D printing of patient-specific surgical solutions and customized workflows, a market expected to reach $5.3 billion by 2032³

ROCK HILL, SC, Sept. 11, 2024 (GLOBE NEWSWIRE) — Today, 3D systems (NYSE:DDD) announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for TOTAL ANKLE Patient-Matched Guides for use with Smith+Nephew’s SALTO TALARIS^◊ Total ankle prosthesis and CADANCE^◊ Total Ankle System. The products feature individualized pre-operative planning and a patient-specific 3D printed instrument set that ensures precise implant alignment and sizing for customized total ankle replacement surgery. The collaboration between 3D Systems and Smith+Nephew, the global medical technology company, has created these patient-specific solutions that enable surgeons to prepare the bony anatomy of the tibia and talus for placement of implants intended to restore proper ankle joint function. These patient-specific guides are designed and manufactured using the VSP surgical planning solutions that combine best-in-class digital workflows with the industry’s broadest portfolio of additive manufacturing printers and materials.

3D Systems’ personalized solutions are designed to enable surgeons to enjoy benefits such as performing surgery with fewer procedural steps, reduced operating room (OR) time,^1-2 and less intraoperative X-ray radiation² compared to procedures using standard non-patient-specific instruments. Ben Johnson, 3D Systems’ vice president, portfolio & regulatory, noted, “With over 25 years of experience, our solutions have supported over 175,000 patient-matched cases with the goal of improving surgical outcomes and the overall patient experience. Our VSP surgical planning workflow, including the expertise of our biomedical engineers, our Selective Laser Sintering technology and our DuraForm ProX PA materials, is a differentiator in the marketplace and was instrumental in the success of this program in a short time frame.”

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