# K220958: Real Intelligence Cori

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Jul 27, 2022 after 117 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: 21 generations back to K905070 (1991). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220255: Real Intelligence Cori, Blue Belt Technologies, Inc. (2022) Summary page 4.

## Indications for use
CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include: * unicondylar knee replacement (UKR), * total knee arthroplasty (TKA), * revision knee arthroplasty, and * total hip arthroplasty (THA).

Source page: https://510kreport.com/device/K220958
Methodology: https://510kreport.com/methodology