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

About This 510(k) Submission

K243817 is an FDA 510(k) clearance for the 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, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on February 6, 2025, 56 days after receiving the submission on December 12, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.