ApolloHipX (THR.SS.0001)

ApolloHipX is intra-operative image processing software that measures and displays the position and alignment of total hip replacement (THR) components in near-real time to assist surgeons in precise implant placement. The software registers pre-operative 3D patient data to 2D intra-operative radiological images and calculates component alignment relative to bone structures, displaying results on a dedicated Apollo Station hardware unit located outside the patient field.

ApolloHipX and its predicate JointPoint produce identical measurement outputs for cup position/orientation and stem measurements (leg length and offset). The key difference is that ApolloHipX accepts pre-operative planning inputs from OPS1nsight with 3D bony landmarks identified from CT, while JointPoint allows users to define landmarks from 2D radiographs. ApolloHipX uses 3D-to-2D registration whereas JointPoint overlays 2D fluoroscopy images, but both provide the same final measurement outputs to the user.

Not stated in this summary.

ApolloHipX demonstrates substantial equivalence to JointPoint (K160284) based on identical intended use for intra-operative THR component alignment measurement and identical measurement outputs. Although ApolloHipX differs technologically by using 3D-to-2D registration with pre-operative CT landmarks instead of 2D-to-2D fluoroscopy overlay, these differences do not raise new safety or effectiveness questions because both systems provide equivalent clinical measurements and guidance. Non-clinical testing including registration repeatability, algorithm accuracy, sawbone, and cadaveric studies confirmed the device performs substantially equivalently to the predicate.