# K163338: OMNIBotics Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Omnllife Science, Inc.
- Decided: Sep 1, 2017 after 277 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: 8 generations back to K002053 (2000). 32 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090953: Total Knee Surgetics Navigation System with Iblock, Praxim Medivision, SA (2010) Summary page 4.
- K150372: VERASENSE Knee System, Orthosensor, Inc. (2016) Summary page 4.
- K132104: Elibra Soft-Tissue Force Sensor, Kamm & Associates (2014) Summary page 4.

## Most influential descendants
- K200888: OMNIBotics Knee System (2020), 11 descendants of its own
- K221224: Real Intelligence Cori (2022), 9 descendants of its own
- K231963: Real Intelligence™ Cori™ (2023), 4 descendants of its own
- K240139: Real Intelligence™ CORI™ (2024), 3 descendants of its own
- K240113: CORIOGRAPH Knee Pre-Op Plan (2024), 2 descendants of its own

## Indications for use
The OMNIBotics® Knee System is indicated for stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics® Knee System supports OMNI Apex Knee™ System implants.

Source page: https://510kreport.com/device/K163338
Methodology: https://510kreport.com/methodology