ProDisc-L
A 3-piece semi-constrained artificial lumbar disc consisting of two metallic end plates and a polythylene inlay that is locked into the bottom end plate
The semi-constrained mechanics of the device allow it to share shear (translational) forces with thte posterior facet joints.
The small keels an titanium plasma-sparyed finish on the end plates allow for immediate fixation as well as longer term bony ingrowth.
The second artificial disc to receive U.S. FDA approval for implantation after successfully completing Investigational Device Exemption (IDE) clinical trials: Several aspects of the clinical trials showed ProDisc-L to be superior to fusion
Multilevel disc replacements are possible with the ProDisc-L device and have been performed at two and three levels: Two-level disc replacement was part of the IDE clinical trials and will be reviewed for FDA approval.
ProDisc-C
A two-piece semiconstrained cervical disc consisting of two metallic end plates and a ployethylene liner fixed to the bottom end plate.
The semiconstrained mechanics of the device allow it to share shear (translational) forces with the posterior facet joints
The plasma sprayed finish and small keels on the end plates allow for immediate fixation as well as longer term bony ingrowth
The enrollment phase of a U.S. pivotal FDA IDE study has been completed for this device, and the 2-year follow-up data for the entire multicenter cohort are being studied before likely full FDA approval for implantation.
Multilevel disc replacements are possible with the ProDisc-C device and have been performed at two and three levels.
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