# K233256: Robotic Integration Instruments

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Jun 17, 2024 after 263 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: 21 generations back to K003155 (2001). 645 ancestors in all.
No later device cites it as a predicate yet.
1 of 646 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200791: Navigation Enabled Intruments, Medos International SARL (2020) Summary page 4.
- K220862: E-GPS Navigated Instruments, Precision Spine, Inc. (2022) Summary page 4.

## Indications for use
Robotic Integration Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which: * the use of EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT is indicated, * the use of stereotactic surgery may be appropriate, and * reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (eg. CT or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System. The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Source page: https://510kreport.com/device/K233256
Methodology: https://510kreport.com/methodology