IMPLANET Receives FDA Clearance in the United States for the 3D Cage Range – Swingo™

03 Mar 2026 17:45 CET

Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME), a medical technology company specializing in implants for orthopedic surgery and the distribution of advanced medical equipment, today announces that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Swingo™ anterior cervical cage.

Developed through the work of a dedicated development group established in 2024 with a panel of international surgeons, the Swingo™ cage range features a broad portfolio of implant sizes with a design tailored to vertebral anatomy, ensuring improved control of interbody fusion. These titanium implants, manufactured using 3D printing technology, can be used for all types of procedures, regardless of the surgical approach chosen by the surgeon. A dedicated next-generation instrumentation range is included in this clearance and is designed to enhance patient safety while reducing surgical time.

Ludovic Lastennet, CEO of IMPLANET, stated: “This new clearance marks an important milestone for IMPLANET. In the short term, combined with JSS (posterior fusion system), it will enable us to offer a comprehensive range of implants dedicated to spinal fusion in the United States, our priority market. The potential synergies created by our expanded product portfolio fully support our strategy to strengthen our presence in the U.S. This represents another structural step in our development plan, aimed at reinforcing our offering in the spine surgery segment within a market estimated at $1.35 billion. This clearance will also allow us to commercialize this range, in addition to our existing portfolio, with many our distributors in countries recognizing U.S. FDA regulations, pending CE marking for the European market.”

Next Financial Release

• Q1 2026 revenue, April 14, 2026, after market close.

About IMPLANET

IMPLANET is a medical technology company that manufactures high-end implants for orthopedic surgery and distributes advanced medical equipment (SMTP and robotics). Its business is built around an innovative solution designed to improve the treatment of spinal pathologies (JAZZ®) and the Jazz Spinal System™ hybrid fixation system, characterized by a comprehensive pedicle screw solution co-developed with Shanghai Sanyou Medical Co., Ltd (“Sanyou Medical”) under the technological partnership entered into in November 2022. These product lines are complemented by the ranges offered by Orthopaedic & Spine Development (OSD), acquired in May 2021 (thoraco-lumbar screws, cages and cervical plates). IMPLANET’s orthopedic platform is notably based on full product traceability. Protected by four families of international patents, JAZZ® has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA), CE marking, ANVISA approval in Brazil, and CFDA approval in China. In 2022, IMPLANET entered into a commercial, technological and financial partnership with SANYOU MEDICAL, the second-largest Chinese manufacturer of medical devices. IMPLANET employs 46 people and generated consolidated revenue of €12.5 million in 2025. Based near Bordeaux, France, IMPLANET has operated a U.S. subsidiary in Boston since 2013. IMPLANET is listed on the Euronext Growth market in Paris.

For more information, please visit www.Implanet.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260303854011/en/

IMPLANET
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tél. : +33 (0)5 57 99 55 55
investors@implanet.com

NewCap
Investor Relations
Mathilde Bohin
Tél. : +33( 0)1 44 71 94 94
implanet@newcap.eu

NewCap
Media Relations
Arthur Rouillé
Tél. : +33 (0)1 44 71 94 94
implanet@newcap.eu