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Robotic Integration Instruments

DePuy Synthes

Country / Region:Switzerland (CH)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

Switzerland (CH)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K233256
Device name
Robotic Integration Instruments
Country / Region
Switzerland(CH)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-09-28
Decision date
2024-06-17
Submission type
Traditional
Technology type
Robotic Navigation(AI inferred)
Clinical applications
Spine SurgeryRobotic AssistanceNavigation System
Primary application
Spine Surgery
Classification source
AI classified

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.

Intended 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.

Device Description

Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves, Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and non-navigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.

Summary parsed at:2026-06-19 05:28:45 UTC

Predicate devices

3

K233256 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K233256 as a predicate