Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert

This submission includes six total knee replacement system components: tibial inserts (Scorpio-Flex Cruciate Retaining, Scorpio-Flex Posterior Stabilized, Scorpio NRG Cruciate Retaining, and Scorpio NRG Posteriorly Stabilized) and patellar components (Scorpio Universal Dome Patella and Scorpio Total Stabilizer Insert). These devices replace bearing and articulating surfaces of the distal femur and proximal tibia to relieve pain, instability, and motion restriction from degenerative joint disease. They are used in total knee arthroplasty procedures via cemented fixation and are intended for single-use only.

The technological characteristics of the subject devices are identical to those of the predicate devices. The labeling updates in this submission have no impact on the technological characteristics of the subject and predicate devices, as stated in the submission.

Not stated in this summary.

The submission is a "Change Being Effected" labeling update adding a contraindication to the Scorpio Total Knee System. All devices have been previously deemed substantially equivalent in prior 510(k) submissions and are already commercially available. Because the technological characteristics, materials, sterilization, design, and operational principles remain identical to the predicate devices (K994128 primary predicate, plus K041591, K011643, K030978, K042343, K972967 as supporting predicates), and the change involves only labeling modification without altering device function or safety profile, substantial equivalence is maintained.