# K243958: Consolidated Operating Room Equipment (CORE) 2 Console

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 21, 2025 after 88 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: 17 generations back to K853033 (1985). 77 ancestors in all.
No later device cites it as a predicate yet.
1 of 78 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241171: Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories, Stryker Leibinger GmbH & Co KG (2024) Summary page 5.

## Indications for use
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

Source page: https://510kreport.com/device/K243958
Methodology: https://510kreport.com/methodology