VERTICALE GPS Instruments

FDA 510(k) K254148 · Silony Medical GmbH

Substantially Equivalent

510(k) numberK254148

Submission

Device name
VERTICALE GPS Instruments
Applicant
Silony Medical GmbH
Leinfelden-Echterdingen, DE
Received
December 22, 2025
Decision date
February 19, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLO – Orthopedic Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other 510(k)s with product code OLO

510(k)DeviceApplicantDecision
K262506Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special Remex Medical Corp.08/20/2026SE
K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional Suite 201, National Innovation Centre07/30/2026SE
K261205SPINEART Navigation Instrument SystemOLO · Traditional Spineart SA07/29/2026SE
K262121Ion-L Navigated InstrumentsOLO · Special SurGenTec, LLC07/24/2026SE
K261024TMINI Miniature Robotic SystemOLO · Traditional THINK Surgical, Inc.07/24/2026SE
K261113Op.n™ Spine Navigation and Robotic GuidanceOLO · Traditional Ecential Robotics07/22/2026SE
K261852OTS HipOLO · Special Ortoma AB07/01/2026SE
K253921VERTICALE® Navigation InstrumentsOLO · Traditional Silony Medical GmbH06/26/2026SE
K260480VELYS™ Robotic-Assisted SolutionOLO · Traditional Depuy Ireland UC06/25/2026SE
K260369Dynamis Robotic Surgical SystemOLO · Traditional LEM Surgical AG06/20/2026SE

More from LEM Surgical AG

510(k)DeviceDecision
K253921VERTICALE® Navigation InstrumentsOLO · Traditional 06/26/2026SE
K223806VERTICALE® Triangular Fixation SystemNKB · Traditional 07/06/2023SE
K223649VERTICALE® Navigation InstrumentsOLO · Special 12/22/2022SE
K212007VERTICALE Navigation InstrumentsOLO · Traditional 08/12/2021SE
K192013VERTICALE® Cervical SystemNKG · Traditional 04/07/2020SE
K190680Favo S-TlifMAX · Traditional 07/18/2019SE
K182608Oyster ACIF CageODP · Traditional 06/13/2019SE
K181899Roccia® PlifMAX · Traditional 12/13/2018SE
K180963Roccia Alif, Roccia TlifMAX · Traditional 07/11/2018SE
K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemNKB · Traditional 01/10/2018SE

Questions and answers

When was VERTICALE GPS Instruments cleared by the FDA?

VERTICALE GPS Instruments (K254148) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 59 days after the submission was received.

What is the product code of K254148?

The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.