SpinePlex bone cement
SpinePlex bone cement is a derivative of Simplex P bone cement and has an average working time of 10- 12 minutes1. It contains the same PMMA as Simplex P and is manufactured using the same proprietary process. Simplex P bone cement has proven through clinical testing to have high fatigue, compressive and flexural strengths, and low creep.
Features
SpinePlex bone cement has proven through clinical testing to have high fatigue2, compressive and flexural strengths3, and low creep4.
- Working time of 10-12 minutes1
- 30% barium sulfate concentration
Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement. Please see the IFU for a complete list of potential risks.
References:
- Stryker data on file for the source information
- Davies J et al. The effect of centrifuging bone cement. J Bone Joint Surg Br. 1989; 71(1):39-42.
- Hansen D and Jensen J. Mixing does not improve mechanical properties of all bone cements. Manual and centrifugation-vacuum mixing compared for 10 cement brands. Acta Orthop Scand 1992; 63(1): 13-18.
- Holm N. The relaxation of some acrylic bone cements. Acta Orthop Scand. 1980; 51(5):727-31.
IVS-SP-SYK-1135689_REV-0