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This month’s collection of FDA cleared technologies from well-established orthopedic players assist in the replacement of shoulders, hips and knees. Arthrex developed a software system for virtual implant positioning and Corin integrated dynamic 3D preoperative planning with intraoperative fluoroscopy to help surgeons develop personalized plans for hip replacement patients. OrthAlign’s new handheld navigation device guides surgeons during hip arthroplasties and Smith+Nephew’s planning software lets surgeons develop patient-specific plans for knee replacement surgery.
Arthrex | Virtual Implant Positioning (VIP) System Software – Shoulder Arthroplasty Implantation System, K241097
Submitted April 2024, granted October 2024
Primary predicate: Arthrex Virtual Implant Positioning (VIP) System software (VIP Web Portal and OrthoVis Preoperative Plan), K230904
FYI: Compared to the predicate, the subject device includes a Range of Motion feature, Osteophyte Removal feature, a Multiple Plan creation feature and minor updates to the user interface.
VIP Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as CT imaging. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis desktop software by trained Arthrex technicians.
The VIP Web Portal is intended for use with VIP glenoid instrumentation and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following implant lines: Univers II and Univers Apex total shoulders, keeled or pegged glenoid components; the Univers VaultLock glenoid component, as well as the Univers Revers baseplate component (Universal Glenoid); and Univers Revers modular glenoid system baseplates. It is also indicated for use with Arthrex humeral implants that are compatible with these implant lines.
Corin | ApolloHipX Application, K241808
Submitted June 2024, granted January 2025
Primary predicate: JointPoint Image Processing, K160284
FYI: ApolloHipX is indicated for use in assisting in total hip replacement in which the use of radiological imaging may be appropriate.
ApolloHipX is reported to be the first hip arthroplasty technology to integrate dynamic 3D preoperative planning with intraoperative fluoroscopy, enabling surgeons to implement a personalized plan with greater precision and efficiency.
The system reconstructs 3D spatial relationships between the implants and bones, providing a more accurate assessment of component position from a single image.
OrthAlign | Lantern Hip, K242616
Submitted September 2024, granted October 2024
Primary predicate: OrthAlign Plus System, K171780
FYI: Lantern Hip is indicated for direct anterior total hip arthroplasty with the patient in the supine position.
Next-generation accelerometers and gyroscopes offer orthopedic surgeons a streamlined workflow, real-time navigation for cup positioning, and restoration of leg length and offset. The technology enables individualized cup positioning across multiple planes, including the functional pelvic plane, anterior pelvic plane and coronal plane, with live pelvic tracking. Designed for personalized patient care, Lantern Hip eliminates the need for preoperative imaging or capital equipment and is compatible with most implant systems, making it suitable for the ASC setting.
Smith+Nephew (Blue Belt Technologies ) | CORIOGRAPH Pre-Op Planning and Modeling Services, K242272
Submitted August 2024, granted November 2024
Primary predicate: Smith+Nephew CORIOGRAPH Knee Pre-Op Plan, K240113
FYI: Indicated for unicondylar knee replacement and total knee arthroplasty.
Exclusively for users of the CORI Surgical System, this innovative planning software allows for use of x-rays or CT scans for preoperative planning and modeling, enabling surgeons to make a patient-specific plan for the best possible outcome.
Advanced modeling capabilities use patient-specific spinopelvic classification and pelvic tilt to help surgeons make decisions on optimal implant placement. Image-agnostic planning capabilities with 2D and/or 3D images help personalize the end-to-end care specific to the patient’s need.
The planning software can also be used across the entire spectrum of Smith+Nephew’s hip implant solutions and technologies.
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