Home › Device types › OLO
Orthopedic Stereotaxic Instrument
FDA product code OLO · Class 2 · Neurology
16,253
Registered devices
20,865
Adverse events
114
Recalls
441
510(k) clearances
Devices with this code
NA — Exactech, Inc.ATEC Posterior Navigation Disc Prep Instruments — ALPHATEC SPINE, INC.MASADA — Astura MedicalPIN CAP — MEDTECHNexxt Spine Navigation System — NEXXT SPINE, LLCCarboClear X Pedicle Screw System — CARBOFIX ORTHOPEDICS LTDSYMPHONY — Medos International SàrlValence Robotic Navigation System — ALPHATEC SPINE, INC.OrthAlign Plus — Orthalign, Inc.OLYMPIC — Astura MedicalMASADA — Astura MedicalValence Robotic Navigation System — ALPHATEC SPINE, INC.Accelus Navigated Reusable Instruments — Integrity Implants Inc.RIVA Posterior Fixation System — XENIX MEDICAL LLCRIVA Pedicle Screw System — XENIX MEDICAL LLCROSA® — Orthosoft IncCD HORIZON® SOLERA® VOYAGER™ Spinal System — MEDTRONIC SOFAMOR DANEK, INC.OLYMPIC — Astura MedicalGPS — Exactech, Inc.Mariner MIS — Seaspine Orthopedics CorporationRIVA Posterior Fixation System — XENIX MEDICAL LLCReLine — Nuvasive, Inc.SOLACE Sacroiliac Fixation System — XENIX MEDICAL LLCDYNAMIS™ Navigation System — PROMETHEAN RESTORATIVE LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-28 | Intellijoint Surgical, Inc. | A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro ba |
| 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 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. |
| 2026-04-23 | 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. |
| 2026-02-10 | 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. |
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