Smith & Nephew · Class II · Cleared Feb 19, 2025
| K-number | K241666 |
| Device name | EVOS Pelvic and Acetabular System |
| Applicant | Smith & Nephew |
| Product code | HRS |
| Device class | Class II |
| Decision date | Feb 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The EVOS Pelvic and Acetabular System is a Class II bone fixation device consisting of metallic plates and screws (locking, non-locking, and cannulated types) manufactured from implant-grade 316L stainless steel. It is indicated for fixation of fractures and disruptions of the pelvis and acetabulum in skeletally mature patients.
The subject plates and screws share the same operating principle, material (316L stainless steel), and technological characteristics as the predicate devices. The plates are compatible with previously cleared EVOS locking and non-locking screws and osteopenia screws, and are available in a variety of shapes and sizes.
ASTM F382 (four-point bend fatigue testing of plates), ASTM F543 (static evaluation of screws), ASTM F1264 (bending fatigue testing of screws), ASTM F2052, F2213, F2182, and F2119 (MRI compatibility), ASTM F2096 and F88 (packaging verification). Finite element analysis (FEA) was also conducted.
The subject device is substantially equivalent because it has identical intended use and indications as the predicate EVOS plating systems, shares the same operating principle and material composition, and nonclinical testing (mechanical fatigue, static strength, and MRI compatibility) demonstrates equivalent performance characteristics to the cleared predicates K162078 and K140814.
View the full FDA submission: accessdata.fda.gov