Medissey has opened the doors of the U.S. Food and Drug Administration (FDA) with its cervical spinal implant product. On the 16th, Medissey announced through a voluntary disclosure that 'NeckTune™ 3D SA Cervical Cage' has obtained FDA 510(k) clearance. The FDA approval date for the product is June 15, 2026.

The newly approved product is a standalone spinal implant used in anterior cervical interbody fusion. A key feature is that additional fixation is possible using screws on the implant without the need for a separate anterior fixation plate.

The product's technological capabilities also draw attention. The company explained that it applied 3D printing additive manufacturing technology to implement a porous structure on the product's surface. This was designed to facilitate osseointegration, where the patient's bone cells grow into the implant and bond with it.

Additionally, unlike the conventional combination method of 'implant and anterior cervical fixation plate,' it adopts a standalone structure that does not require a separate metal plate. This has significantly improved convenience during the surgical process and can reduce irritation to surrounding soft tissues and adjacent spinal segments.

Medissey plans to further strengthen the competitiveness of its spinal implant product line in the U.S. market, taking this FDA approval as an opportunity. The company expects this to diversify its product portfolio and contribute to increased sales. The approved product is classified as a Class II medical device in the United States, and the certification has no separate expiration date.

Meanwhile, the company projects that related sales will begin in the second half of 2026 following this approval. However, it added that the specific sales scale has not yet been determined and may fluctuate depending on future market conditions.