Altus Spine Navigation System

FDA 510(k) K243419 · Altus Partners, LLC

Substantially Equivalent

510(k) numberK243419

Submission

Device name
Altus Spine Navigation System
Applicant
Altus Partners, LLC
West Chester, PA, US
Received
November 4, 2024
Decision date
May 8, 2025
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
K211027Altus Spine Pedicle Screw SystemNKB · Traditional 09/16/2022SE
K211837Altus Spine Interbody Standalone Fusion SystemOVD · Traditional 04/19/2022SE
K210887Altus Spine Sochi OCT Spinal SystemNKG · Traditional 08/20/2021SE
K200922Altus Spine HA Pedicle Screw SystemNKB · Special 01/26/2021SE
K200322Altus Spine Pedicle Screw SystemNKB · Traditional 06/02/2020SE
K183084Fuji Cervical Plate SystemKWQ · Special 05/29/2019SE
K182406Altus Spine Interbody Fusion SystemMAX · Traditional 02/22/2019SE
K181339Altus Spine Pedicle Screw SystemNKB · Traditional 07/24/2018SE
K181281Altus Spine Pedicle Screw SystemNKB · Special 06/11/2018SE
K170553Altus Spine Interbody Fusion SystemMAX · Traditional 12/01/2017SE

Questions and answers

When was Altus Spine Navigation System cleared by the FDA?

Altus Spine Navigation System (K243419) received a 510(k) decision of Substantially Equivalent on May 8, 2025, 185 days after the submission was received.

What is the product code of K243419?

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