FDA product code OLO: Orthopedic Stereotaxic Instrument
OLO is the FDA product code for orthopedic stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel. FDA has cleared 440 510(k) submissions under OLO, 207 in the last five years, from 145 different applicants. The average 510(k) review took 121 days (median 96); 121 days on average over the last three years. FDA has posted 113 recalls for OLO devices, 51 initiated in the last five years.
Definition
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Classification
| Field | Value |
|---|---|
| Device name | Orthopedic Stereotaxic Instrument |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OLO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 33 | 99 |
| 2018 | 24 | 119 |
| 2019 | 35 | 145 |
| 2020 | 34 | 121 |
| 2021 | 28 | 110 |
| 2022 | 40 | 107 |
| 2023 | 45 | 105 |
| 2024 | 44 | 119 |
| 2025 | 40 | 129 |
| 2026 | 38 | 115 |
Compare with all 510(k) review times · Search every OLO clearance
Top OLO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brainlab AG | 21 | 2025-09-12 |
| THINK Surgical, Inc. | 19 | 2026-07-24 |
| Mako Surgical Corp. | 19 | 2026-02-25 |
| Blue Belt Technologies, Inc. | 18 | 2026-03-26 |
| Medtronic Sofamor Danek USA, Inc. | 15 | 2023-05-26 |
140 more applicants have OLO clearances. See the full list in Caduvo.
Most recent OLO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262506 | Remex Medical Corp. | Remex Spine Surgery Navigation - Universal Instruments | 2026-08-20 | 30 |
| K261410 | Suite 201, National Innovation Centre | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | 2026-07-30 | 91 |
| K261205 | Spineart SA | SPINEART Navigation Instrument System | 2026-07-29 | 107 |
| K261024 | THINK Surgical, Inc. | TMINI Miniature Robotic System | 2026-07-24 | 116 |
| K262121 | SurGenTec, LLC | Ion-L Navigated Instruments | 2026-07-24 | 31 |
Recalls for OLO devices
113 product recalls in 85 recall events; 51 initiated in the last five years and 50 still open. Most recent: 2026-07-23.
| Year | Recalls |
|---|---|
| 2017 | 14 |
| 2018 | 5 |
| 2019 | 8 |
| 2020 | 12 |
| 2022 | 6 |
| 2023 | 10 |
| 2024 | 13 |
| 2025 | 13 |
| 2026 | 9 |
Frequently asked questions
What is FDA product code OLO?
OLO is the FDA product code for orthopedic stereotaxic instrument. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Orthopedic panel.
What device class is OLO?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLO?
Across 440 cleared submissions the average was 121 days from receipt to decision (median 96).
Which companies have the most OLO clearances?
Brainlab AG (21); THINK Surgical, Inc. (19); Mako Surgical Corp. (19); Blue Belt Technologies, Inc. (18); Medtronic Sofamor Danek USA, Inc. (15).
Have OLO devices been recalled?
Yes: 113 product recalls across 85 recall events; the most recent began 2026-07-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OLO
- Run a recall and safety report across every OLO manufacturer
- Watch product code OLO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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