# K243419: Altus Spine Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: May 8, 2025 after 185 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: 21 generations back to K853033 (1985). 389 ancestors in all.
No later device cites it as a predicate yet.
1 of 390 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170679: CD HORIZON® Spinal 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 (2017) Summary page 5.
- K230766: Altus Spine Monaco Pedicle Screw System, Altus Spine (2023) Summary page 5.
- K181281: Altus Spine Pedicle Screw System, Altus Partners, LLC (2018) Summary page 5.

## Indications for use
The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, 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 for the anatomy. • For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System. The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K243419
Methodology: https://510kreport.com/methodology