# K240139: Real Intelligence™ CORI™

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Mar 18, 2024 after 60 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K905070 (1991). 72 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231963: Real Intelligence™ Cori™, Blue Belt Technologies, Inc. (2023) Summary page 4.

## Most influential descendants
- K260601: Real Intelligence™ Cori™ (2026), 0 descendants of its own
- K252841: Real Intelligence™ Cori™ XT (Cori XT) (2025), 0 descendants of its own
- K251971: RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer (2025), 0 descendants of its own

## Recalls of this device
- May 7, 2024 · Class II · Z-2135-2024: CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, a

## 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/K240139
Methodology: https://510kreport.com/methodology