# K260601: Real Intelligence™ Cori™

- Pathway: 510(k) (Special)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Mar 26, 2026 after 30 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: 24 generations back to K905070 (1991). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240139: Real Intelligence™ CORI™, Blue Belt Technologies, Inc. (2024) Summary page 5.

## Indications for use
REAL INTELLIGENCE 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/K260601
Methodology: https://510kreport.com/methodology