# K230876: RI.KNEE Adjustable Tibia Cut Guide

- Pathway: 510(k) (Traditional)
- Applicant: Enztec Limited
- Decided: Jun 27, 2023 after 89 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: 22 generations back to K905070 (1991). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 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.

## Indications for use
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.

Source page: https://510kreport.com/device/K230876
Methodology: https://510kreport.com/methodology