ApolloHipX (THR.SS.0001)
Corin USA LimitedApolloHipX is a software system designed to aid surgeons during Total Hip Replacement by precisely measuring the position and alignment of hip replacement components using radiological images. It integrates pre-operative 3D patient data with intra-operative 2D X-ray images to provide near-real-time assistive measurements, helping ensure the implants are correctly positioned relative to the patient's bone structures.
Intended Use
ApolloHipX is indicated for use in assisting in Total Hip Replacement in which the use of radiological imaging may be appropriate.
Technology
ApolloHipX is intra-operative image processing software that transfers 2D radiological images, registers 3D pre-operative patient data to these images, and calculates and displays implant component alignment relative to bone structures. It operates on certified hardware named Apollo Station and provides near-real-time assistive measurements to surgeons.
Performance
Non-clinical testing included software and system landmark repeatability and reproducibility studies, algorithm accuracy, a sawbone study, cadaveric evaluation, and comparison against predicate devices. No clinical testing was performed. Test results demonstrated substantial equivalence and safety.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/21/2024
6 months - 2
FDA Approval
1/7/2025
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