# K243817: 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 - Pathway: 510(k) (Traditional) - Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics - Decided: Feb 6, 2025 after 56 days - Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer) - Device class: 2 - Regulation: 21 CFR 888.3560 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K915192 (1992). 12 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 15 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K994128: Scorpio Total Stablizer (TS) Total Knee System, Howmedica Osteonics Corp. (2000) Summary page 6. - K041591: Scorpio-Flex Posterior Stabilized Tibial Insert Components, Howmedica Osteonics Corp. (2004) Summary page 7. - K011643: Scorpio CR Superflex Tibial Insert, Howmedica Osteonics Corp. (2001) Summary page 7. - K030978: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2003) Summary page 7. - K042343: Scorpio NRG Knee System, Howmedica Osteonics Corp. (2005) Summary page 7. - K972967: Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total Knee Recessed Patellar Component, Osteonics Corp. (1998) Summary page 7. ## Most influential descendants - K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own - K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (2025), 0 descendants of its own ## Recalls of this device - Jul 30, 2026 · Class II · Z-3206-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m - Jul 30, 2026 · Class II · Z-3197-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m ## Indications for use Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert: • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert: The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of: • Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure Additional indications for the Posterior stabilized components include: • Ligamentous instability requiring implant bearing surface geometries with increased constraint • Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio-Flex Posterior Stabilized Tibial Insert: • Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function; moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure • Ligamentous instability requiring implant bearing surface geometries with increased constraint • Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert: The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of • Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized Devices: • Ligamentous instability requiring implant bearing surface geometries with increased constraint • Absent or non-functioning posterior cruciate ligament. Indications for the Osteonics Scorpio Universal Dome Patella: • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio Total Stabilizer Insert: General TKR Indications • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability • Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components: • Ligamentous instability requiring implant bearing surface geometries with increased constraint • Absent or non-functioning posterior cruciate ligament • Severe anteroposterior instability of the knee joint • For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function Indications for Bone Augmentation Wedges: • Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss • Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss Source page: https://510kreport.com/device/K243817 Methodology: https://510kreport.com/methodology