Home › Device types › OLO
Orthopedic Stereotaxic Instrument
FDA product code OLO · Class 2 · Neurology
15,476
Registered devices
20,328
Adverse events
113
Recalls
439
510(k) clearances
Devices with this code
Anteralign Spinal System with Titan nanoLock Surface technology — MEDTRONIC SOFAMOR DANEK, INC.Lantern — Orthalign, Inc.OMNIBotics — Omni Life Science, Inc.OLYMPIC — Astura MedicalOLYMPIC — Astura MedicalSpecials — Seaspine Orthopedics CorporationValence Robotic Navigation System — ALPHATEC SPINE, INC.OLYMPIC — Astura MedicalEquinoxe — Exactech, Inc.CD HORIZON® SOLERA® VOYAGER™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.CD HORIZON® SOLERA® VOYAGER™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.Fem&Tib Cut Block Adp Universal Ii — Brainlab SEAdapter For Rectangular Instruments — Brainlab SEQ Interbody Instruments — VB Spine LLCSIros-X — Genesys Orthopedics Systems LLCiASSIST — Orthosoft IncRIVA Pedicle Screw System — XENIX MEDICAL LLCRIVA Posterior Fixation System — XENIX MEDICAL LLCInvictus — ALPHATEC SPINE, INC.Bl Offset Cup Impactor Universal — Brainlab SENavigation Instruments — VB Spine LLCSalvo® XRS Robotic Navigation Instrument System — Spine Wave, Inc.MASADA — Astura MedicalMASADA — Astura Medical
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-23 | Medos International Sarl | Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. |
| 2026-05-08 | Think Surgical, Inc. | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. |
| 2026-04-23 | Kico Knee Innovation Company | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. |
| 2026-04-23 | Kico Knee Innovation Company | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. |
| 2026-02-10 | Orthalign, Inc | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| 2026-02-10 | Orthalign, Inc | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| 2026-02-02 | Howmedica Osteonics Corp. | A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cov |
| 2026-01-02 | Alphatec Spine, Inc. | Due a design issue where the navigated array connection geometry is incorrect. |
| 2026-01-02 | Alphatec Spine, Inc. | Due a design issue where the navigated array connection geometry is incorrect. |
| 2025-12-10 | Mazor Robotics Ltd | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. |
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