# K203751: OMNIVision system

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Apr 12, 2021 after 110 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010612 (2001). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172849: Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray, Intellijoint Surgical, Inc. (2017) Summary page 4.
- K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000, Stryker Instruments (2005) Summary page 4.

## Indications for use
The OMNIVisionTM system is intended to be used as an intra-operative system to assist in the alignment of prosthetic components during Total Hip Arthroplasty, where a reference to a rigid anatomical structure can be identified. The system achieves this by displaying intra-operative measurements of the acetabular component to the user calculated from visual information from a camera detecting fiducial markers. The OMNIVisionTM system is compatible for use with the legally marketed products * OPSInsightM and * the Corin Trinitym Acetabular System, * Trinity-iTm Acetabular shells and * TrinitvTM non-occluded titanium plasma sprayed (TPS) acetabular shells. The OMNIVisionTM system is indicated for use with the posterior, anterolateral and direct anterior surgical approaches for primary Total Hip Arthroplasty.

Source page: https://510kreport.com/device/K203751
Methodology: https://510kreport.com/methodology