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Robotic Graft Delivery Instruments

Medtronic Sofamor Danek, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

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Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K230716
Device name
Robotic Graft Delivery Instruments
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2023-03-15
Decision date
2023-07-18
Submission type
Traditional
Technology type
Stereotactic Surgery(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition, which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools. Do not implant instruments.

Intended Use

Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

Device Description

The robotic graft delivery instruments are non-sterile re-usable instruments that may be used during the preparation and placement of various graft material during spinal surgery. The subject instruments are made of a medical grade stainless steel commonly used in orthopedic procedures, which meet available national or international standards specifications. The robotic graft delivery instruments are intended to be used when preparing and placing graft material during spinal surgery. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work through the MAZOR X arm guides. The instruments will be provided non-sterile and reusable.

Summary parsed at:2026-06-19 05:44:48 UTC

Predicate devices

2

K230716 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K230716 as a predicate