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510(k) Data Aggregation
K Number
K240938Device Name
The Optimotion Blue Plus Knee System
Manufacturer
Date Cleared
2024-06-27
(83 days)
Regulation Number
888.3565Why did this record match?
Applicant Name (Manufacturer) :
Optimotion Implants LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Post-traumatic loss of knee joint configurations and function.
· Moderate Varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Revision of previous unsuccessful knee replacement or other procedure.
- · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture-management techniques.
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
- · Severe anteroposterior instability of the knee joint
· Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System non-porous implant components are indicated for cemented use only.
· Optimotion™ Blue Plus Knee System and Optimotion™ Blue Total Knee System porous coated implant components are indicated for cemented or uncemented use.
Device Description
The Optimotion™ Blue Plus Knee System is a line addition to the Optimotion™ Blue Total Knee System (K191084) consisting of a posterior stabilizing (PS) femoral and PS tibial insert components. The femoral component is composed of CoCrMo alloy, non-porous for cemented use. The femoral component is to be used with PMMA bone cement. The tibial insert components are composed of UHMWPE with Vitamin E. The Optimotion™ Blue Plus Knee System is intended for cemented replacement of the femur and articulating surfaces of the knee.
Femoral Component: The femoral component is symmetric. The femoral component is available in posterior stabilizing (PS) design and is offered in eight (8) sizes. The system is designed to allow each size femoral component to be interchangeable with the next size up, the same size, or the next size down Optimotion™ Blue Tibial Tray and corresponding Optimotion™ Blue Plus PS Tibial Insert.
Tibial Inserts: The PS Tibial Insert components are symmetric and available in three configurations for varying levels of constraint. The three configurations from lowest to highest constraint are Low Post (LP), Low Post Plus (LP+), and High Post (HP). The LP Tibial Insert has the shortest and smallest perimeter post and the HP Tibial Insert has the highest and largest perimeter post, with the LP+ containing a post that is between the LP and HP post sizes. Each configuration of PS Tibial Insert is offered in eight (8) sizes and seven (7) thicknesses. The tibial insert components are compatible with the Tibial Tray Components of the Optimotion™ Blue Total Knee System.
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