# K231963: Real Intelligence™ Cori™

- Pathway: 510(k) (Special)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Aug 1, 2023 after 29 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K905070 (1991). 71 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K221224: Real Intelligence Cori, Blue Belt Technologies, Inc. (2022) Summary page 4.

## Most influential descendants
- K240139: Real Intelligence™ CORI™ (2024), 3 descendants of its own
- 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
- Nov 13, 2023 · Class II · Z-0708-2024: Possibility that the user is unable to resolve drill disconnection error messages.
- Sep 7, 2023 · Class II · Z-0041-2024: CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the fe

## 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/K231963
Methodology: https://510kreport.com/methodology