Corin U.S.A. Limited · Class II · Cleared Jun 5, 2025
| K-number | K242744 |
| Device name | Trinity EVO Acetabular Shell |
| Applicant | Corin U.S.A. Limited |
| Product code | LPH |
| Device class | Class II |
| Decision date | Jun 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3358 |
The Trinity EVO Acetabular Shell is a hemispherical titanium alloy hip socket component for total hip replacement surgery. It is used to treat degenerative joint diseases, rheumatoid arthritis, developmental hip dysplasia, and revision cases, and is designed for cementless fixation in skeletal mature patients.
The Trinity EVO uses titanium alloy (Ti6Al4V) with a porous outer structure manufactured via additive manufacturing (Laser Powder Bed Fusion). The inner shell design, dimensions, and locking mechanisms are identical to the predicate Trinity PLUS. It includes an electrochemically deposited calcium phosphate coating and is available with or without screw holes, mirroring predicate sizing and mating features.
ASTM F1044-05(2017) for static shear; ISO 13314:2011 for compression; ISO 7206-12:2016 for deformation; ASTM F1820-22 for liner disassembly; DIN EN ISO 4287:1998+A1:2009 for roughness; ASTM F1978-22 for abrasion; ASTM F3090-20 for shell fatigue; ASTM F1854-15 for porous structure; ASTM F2459-18 for residual powder gravimetric testing.
The Trinity EVO shares identical indications for use, sizing, and liner mating features with predicate Trinity PLUS (K172551). Since the inner shell geometry and locking mechanisms are unchanged from the predicate, prior testing on Trinity PLUS is directly applicable. The additive-manufactured porous outer structure parallels the predicate design, and new testing on the EVO confirms mechanical performance is equivalent. The secondary predicate (REDAPT) provides additional support for the titanium alloy material and porous structure composition.
View the full FDA submission: accessdata.fda.gov