Manufacturer
DePuy SynthesRobotic Integration Instruments
Country / Region:Switzerland (CH)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K233256
- Device name
- Robotic Integration Instruments
- Company
- DePuy Synthes
- 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—
—
Not ingested
E-GPS Navigated Instruments
TriALTIS Navigation Enabled Instruments
K233256 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K233256 as a predicate
