Titanium-PEEK “Two-Track” Lineup Complete—Medyssey Targets the U.S. Cervical Market

[Financial News] Medyssey has laid the groundwork for entering the U.S. market with a standalone cervical implant made of PEEK, following its titanium product.
Medyssey, a company specializing in spinal and orthopedic implants, announced on the 6th that it had received Food and Drug Administration (FDA) 510(k) clearance for the NeckTune SA Cervical Cage, a standalone cervical interbody fusion implant made of polyetheretherketone (PEEK). The FDA 510(k) process involves the FDA reviewing whether a medical device is substantially equivalent to a device already legally marketed in the United States, allowing it to be sold there.
The NeckTune SA Cervical Cage is used in anterior cervical interbody fusion, a procedure that stabilizes the space between the cervical vertebrae through an anterior approach. Its spacer, which maintains the gap between the vertebrae, is made of PEEK, while its plate, which secures the screws, is made of 3D-printed titanium alloy.
PEEK has an elastic modulus closer to that of human bone than metal and is radiolucent, making it easier to assess postoperative bone fusion through imaging tests such as X-rays and CT scans. Its standalone design integrates anterior cervical fixation into the implant, allowing surgery to be performed without a separate anterior fixation plate.
Last June, Medyssey also received FDA 510(k) clearance for the NeckTune 3D SA Cervical Cage, a standalone cervical implant made of 3D-printed titanium. With the addition of the PEEK product, the company now offers a lineup of standalone cervical cages made from two materials—titanium and PEEK—allowing physicians to choose a product based on their clinical judgment and preferences. Medyssey expects related revenue to begin in the first half of 2027 after preparing for local sales.
CEO Sung Kyung-soo said, "With this FDA 510(k) clearance, we have expanded our lineup to include a PEEK standalone cervical cage, further strengthening our competitiveness in the U.S. market. We will continue to reinforce our growth platform in the global medical device market through ongoing research and development and expanded overseas regulatory approvals."
Medyssey pioneered the patient-specific implant field by becoming the first company in South Korea to introduce metal 3D-printing equipment. It supplies spinal implants and 3D-printed customized implants in South Korea and overseas, while expanding its global business through overseas subsidiaries and sales networks in the United States, Chile and Thailand.
[email protected] Jung Myung-jin, medical correspondent
 


[email protected] Jung Myung-jin, medical correspondent Reporter