# K193120: Real Intelligence Cori

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Feb 14, 2020 after 94 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: 17 generations back to K905070 (1991). 46 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191223: NAVIO, Blue Belt Technologies, Inc. (2019) Summary page 4.

## Most influential descendants
- K201022: Real Intelligence Cori (Cori) (2020), 13 descendants of its own
- K212537: Real Intelligence Cori (Cori) (2021), 12 descendants of its own
- K220255: Real Intelligence Cori (2022), 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

## Indications for use
CORI is indicated for use in unicondylar knee replacement (UKR) surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. CORI is indicated for use with cemented implants only.

Source page: https://510kreport.com/device/K193120
Methodology: https://510kreport.com/methodology