# K191854: Premia Spine XL Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Premia Spine, Ltd.
- Decided: Oct 8, 2019 after 90 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: 15 generations back to K853033 (1985). 249 ancestors in all.
No later device cites it as a predicate yet.
0 of 250 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153442: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 4.

## Indications for use
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures. Premia Spine XL Instruments are specifically designed for use with the Medtronic StealthStation System, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic’s StealthStation Navigation System.

Source page: https://510kreport.com/device/K191854
Methodology: https://510kreport.com/methodology