# K251073: Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jul 23, 2025 after 106 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K040583 (2004). 545 ancestors in all.
No later device cites it as a predicate yet.
1 of 546 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.
- K250182: Innovasis Navigation Instruments, Innovasis, Inc. (2025) Summary page 5.
- K241276: Vector™ Pedicle Screw System, Innovasis, Inc. (2024) Summary page 5.
- K102248: Excella II Spinal System Model EC2-00, Innovasis, Inc. (2010) Summary page 5.

## Recalls of this device
- May 22, 2026 · Class II · Z-2859-2026: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition whi

## Indications for use
The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS 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 of the anatomy.

Source page: https://510kreport.com/device/K251073
Methodology: https://510kreport.com/methodology