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The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in the distal femur and patella, patients with a history of patellar fracture and those patients with failed previous surgery where pain, deformity or dysfunction persists. The device is a singleuse implant that is intended for use with bone cement.

The RBK Patella Femoral Knee System consists of femoral and patellar components.

The femoral component is anatomic in design, to provide coverage of the condyles from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A group of four pegs (posts) on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01.

The patella components are offered in one configuration; circular, domed, all UHMWPE. The polymer components are manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The domed, all poly patella buttons are available in 5 diameters (24mm - 40mm).

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, ground truth, or adjudication methods.

The document is a 510(k) premarket notification letter from the FDA regarding the RBK Patella Femoral Knee System. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the sponsor must meet. It focuses on the regulatory approval process and the intended use of the device, rather than detailed study results or performance metrics.

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