Table 3.
Results of the Mechanical Testing of the Mobi-C and the Prodisc-C According to the FDA Summary of Safety and Effectiveness Data (SSED) Compared to Results of the MOVE-C
| MOVE-C | Mobi-C40 | Prodisc-C41 | |
|---|---|---|---|
| Static expulsion test | Ultimate load: 202.3 ± 8.43 N (100 N preload) |
Expulsion load: 142 N ± 18 N (100 N preload) |
Ultimate load: 303.9 N ± 29.6 N (45 N preload) |
| Static compression test | Yield load: >20 kN |
Yield load: 1935 ± 109 N |
— |
| Dynamic compression test | Run-out: 1000 N |
Endurance limit: 1125 N |
— |
| Static compression-shear test | Yield load: 2983 ± 438.2 (shear angle 27°) |
Yield load: 454.4 ± 114.6 N (shear angle 45°) |
Yield load: 1589 N ± 62.7 N (shear angle 18°) |
| Dynamic compression-shear test | Run-out: 1000 N (shear angle 27°) |
Run-out: 450 N (shear angle 45°) |
Run-out: 1300 N (shear angle 18°) |
| Static subsidence test | Yield load: 1287 ± 17.1 N |
Offset load: 1039 N ± 25 N |
— |