# K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Feb 19, 2026 after 188 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: 33 generations back to K841189 (1984). 1,560 ancestors in all.
1 later device descends from it; 1 cites it directly.
7 of 1,562 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232413: Fusion Robotic Navigation System, Alphatec Spine, Inc. (2023) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 6.
- K232345: ATEC Posterior Navigated Disc Prep Instruments, Alphatec Spine, Inc. (2023) Summary page 6.
- K240951: Invictus Robotic Navigation Instruments, Alphatec Spine (2024) Summary page 6.
- K200936: Invictus™ CT Spinal Fixation System, Alphatec Spine, Inc. (2020) Summary page 6.
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 6.
- K234092: SafeOp 3: Neural Informatix Systeem, Alphatec Spine, Inc. (2024) Summary page 6.

## Most influential descendants
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
Valence Robotic Navigation System: Valence Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Valence Robotic Navigation System is indicated for assisting surgeons in spinal procedures, such as: • Pedicle screw placement • Interbody device placement Valence Robotic Navigation Instruments (for use with the StealthStation™): The Valence Posterior Disc Prep Instruments are indicated to facilitate discectomy, bony resection, and implant selection during spinal surgery. The Valence Posterior Fixation Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Navigated 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 of the anatomy.

Source page: https://510kreport.com/device/K252597
Methodology: https://510kreport.com/methodology