Product Application
The PIR is intended for the treatment of symptomatic cartilage defects in patients who have had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage, and also patients who have failed (or are not candidates for) cartilage regeneration techniques. The implant is designed to restore the articular surface of a chondral or osteochondral lesion of the medial femoral condyle (MFC) or patellofemoral groove (PFG) in order to relieve pain and restore function, while preserving as much host bone and intact cartilage as possible. This allows the implant to restore normal anatomic surface geometry and joint congruity without compromising future reconstructive options.
The implantation procedure can be performed in an out-patient setting and utilizes a complete instrument kit, which includes alignment guides, cutters, and trials to ensure optimal implant size, orientation, and placement.
The PIR is a single component that consists of an articular surface cap on a tapered and grooved stem with bone-contacting surfaces coated with hydroxylapatite (HA) for fixation. The symmetric or oval articular cap restores the articular surface of a chondral or osteochondral defect of the anterior or central medial femoral condyle. The stem supports the articular surface cap and is press fit into the prepared subchondral and cancellous bone to provide stability and fixation to bone.
Extensive pre-clinical studies were performed to support the safety and effectiveness of the PIR System. Pre-clinical testing included two large animal in vivo studies, in vitro mechanical strength testing, finite element analysis (FEA) and modeling, material biocompatibility evaluations and MRI compatibility studies. Recognized standards were used in the design and conduct of these non-clinical studies where appropriate. All pre-clinical studies demonstrated that the PIR-MFC system is a robust, durable and biocompatible implant capable of restoring the articulation of the medial condyle while maintaining a high level of performance for the long term.
