# K230716: Robotic Graft Delivery Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Jul 18, 2023 after 125 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: 19 generations back to K911783 (1994). 134 ancestors in all.
No later device cites it as a predicate yet.
4 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182121: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 4.
- K230064: Mazor X System (Mazor X Stealth Edition), Mazor Robotics, Ltd. (2023). Cleared while this submission was under review Summary page 4.
- (no number) Graft Gun: named in the summary without a submission number

## 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. Medtronic does not and cannot warrant the use of these instruments nor any of the component parts upon which repairs have been made or attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Source page: https://510kreport.com/device/K230716
Methodology: https://510kreport.com/methodology