Corcym S.r.l. · Class II · Cleared Apr 14, 2026
| K-number | K260498 |
| Device name | TriMemo SEMIRIGID ANNULOPLASTY RING |
| Applicant | Corcym S.r.l. |
| Product code | KRH |
| Device class | Class II |
| Decision date | Apr 14, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.3800 |
The TriMemo is a semirigid annuloplasty ring designed to treat tricuspid valve insufficiency by reshaping the tricuspid annulus and restoring proper leaflet coaptation. It consists of an electropolished Nitinol core embedded in a silicone sewing ring with polyester fabric coated with Carbofilm carbon. The device is available in 6 sizes (26–36 mm) and is supplied sterile for single use only.
Both TriMemo and the predicate (Carpentier-Edwards Physio K103520) are open semirigid rings with metallic cores covered in polyester cloth, supplied sterile and non-pyrogenic for single use. TriMemo exhibits modular 3D flexibility with higher stiffness in the posterior portion and open ends to avoid conduction system interference. Minor design and material differences exist but do not raise new safety or effectiveness concerns, as the materials are standard for annuloplasty rings.
Testing followed FDA 'Guidance for Annuloplasty Rings 510(k) Submissions,' ISO 5910, ASME V&V 40-2018, ASTM F2052-21, ASTM F2213-17, ASTM F2182-19e2, ASTM F2119-24, ASTM F2503-23e1, ISO 17665:2024, ISO 11138-1:2017, ISO 11138-3:2017, ISO 11737-2:2019, ASTM D4332:2022, ASTM D4169:2024, ASTM F1980:2016, ASTM F1886:2016, ASTM F88:2023, and ASTM F2096:2011.
TriMemo is substantially equivalent to the predicate based on identical intended use (treating tricuspid insufficiency via annular remodeling), shared design as an open semirigid ring, common materials and sterilization methods, and nonclinical testing demonstrating equivalent mechanical strength, fatigue resistance, MRI safety, and usability. Technological differences do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov