FDA product code · Neurology
OLOOrthopedic Stereotaxic Instrument
Product code OLO covers Orthopedic Stereotaxic Instrument, a Class II device regulated under 21 CFR 882.4560. FDA has cleared 437 devices in this code, 51 of them in the last 12 months. Median review time across the 437 most recent decisions is 97 days. openFDA lists 112 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 882.4560
- Review panel
- Neurology
- Clearances
- 437
What is happening in OLO right now?
OLO (Orthopedic Stereotaxic Instrument) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2716-2026, Z-2292-2026, Z-2293-2026, Z-1629-2026, Z-1630-2026). 9 first-time filers in the last 12 months, including Pytheas Navigation Sas and Foundation Surgical Group, Inc (K252880, K260011, K253604, K252058, K252962). The code is crowded, scoring 95 of 100 — 127 companies hold a clearance here and 51 arrived in the last 12 months (OLO:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2716-2026, Z-2292-2026, Z-2293-2026, Z-1629-2026, Z-1630-2026 |
| New entrant | Worth knowing | K252880, K260011, K253604, K252058, K252962 |
| Crowding | Context | OLO:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code OLO cover?
OLO is FDA's product code for Orthopedic Stereotaxic Instrument, a Class II device regulated under 21 CFR 882.4560.
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Source: openFDA device/classification · record OLO · retrieved
How many devices has FDA cleared in OLO?
FDA has cleared 437 devices under product code OLO since the 510(k) programme began in 1976, 51 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262121 | Ion-L Navigated Instruments | SurGenTec, LLC | |
| K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | |
| K261113 | Op.n Spine Navigation and Robotic Guidance | Ecential Robotics | |
| K261852 | OTS Hip | Ortoma AB | |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | |
| K260480 | VELYS Robotic-Assisted Solution | Depuy Ireland UC | |
| K260369 | Dynamis Robotic Surgical System | LEM Surgical AG | |
| K261665 | CORUS Navigation System-GN | Providence Medical Technology, Inc. | |
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | |
| K261060 | Navigated LLIF Impactable Tracker | Tyber Medical, LLC |
How long does FDA review take for OLO?
The median FDA review time for OLO is 97 days, measured across the 437 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in OLO?
openFDA lists 112 recall records against product code OLO. A recall record covers one firm's corrective action and may span many device lots.
Z-2716-2026Open, ClassifiedThink Surgical, Inc.
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Z-2292-2026Open, ClassifiedKico 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.
Z-2293-2026Open, ClassifiedKico 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.
Z-1629-2026Open, ClassifiedOrthalign, Inc
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Z-1630-2026Open, ClassifiedOrthalign, Inc
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Showing the 5 most recently initiated of 112. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for OLO?
MAUDE holds 7,128 adverse-event reports naming product code OLO, 1,908 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in OLO unusual?
One month sits above OLO's own expected range: 1 January 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 73 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 140 | Insufficient history | No expected range — too little history | |
| 63 | Insufficient history | No expected range — too little history | |
| 86 | Insufficient history | No expected range — too little history | |
| 85 | Insufficient history | No expected range — too little history | |
| 77 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 118 | Insufficient history | No expected range — too little history | |
| 136 | Insufficient history | No expected range — too little history | |
| 196 | Insufficient history | No expected range — too little history | |
| 220 | Insufficient history | No expected range — too little history | |
| 159 | Insufficient history | No expected range — too little history | |
| 159 | Insufficient history | No expected range — too little history | |
| 129 | Insufficient history | No expected range — too little history | |
| 175 | Insufficient history | No expected range — too little history | |
| 218 | Insufficient history | No expected range — too little history | |
| 222 | Insufficient history | No expected range — too little history | |
| 247 | Insufficient history | No expected range — too little history | |
| 213 | Insufficient history | No expected range — too little history | |
| 280 | Insufficient history | No expected range — too little history | |
| 515 | 134–283 | Above expected (134–283) | |
| 297 | 89–437 | Within expected (89–437) | |
| 209 | 100–512 | Within expected (100–512) | |
| 238 | 72–498 | Within expected (72–498) | |
| 192 | 58–450 | Within expected (58–450) | |
| 263 | 46–442 | Within expected (46–442) | |
| 206 | 98–688 | Within expected (98–688) | |
| 260 | 28–483 | Within expected (28–483) | |
| 224 | 33–507 | Within expected (33–507) | |
| 232 | 17–493 | Within expected (17–493) | |
| 217 | 7–440 | Within expected (7–440) | |
| 341 | 6–486 | Within expected (6–486) | |
| 257 | 44–600 | Within expected (44–600) | |
| 243 | 124–382 | Within expected (124–382) | |
| 218 | 169–375 | Within expected (169–375) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in OLO.
Who has entered OLO in the last year?
8 companies filed in OLO for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Pytheas Navigation Sas | K252880 | |
| Foundation Surgical Group, Inc. | K260011 | |
| SurGenTec, LLC | K253604 | |
| Balmoral Medical, LLC | K252058 | |
| Promethean Restorative Inc. | K252962 | |
| Orthofix US, LLC | K252088 | |
| Tyber Medical | K252742 | |
| Osteocentric Technologies D.B.A. Osteocentric Trauma | K250520 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in OLO?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in OLO?
Across the 437 most recent decisions, these applicants filed most often in OLO.
| Applicant | Recent clearances |
|---|---|
| Brainlab AG | 21 |
| Mako Surgical Corp. | 19 |
| THINK Surgical, Inc. | 19 |
| Blue Belt Technologies, Inc. | 18 |
| Medtronic Sofamor Danek USA, Inc. | 15 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in OLO files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Mako Surgical Corporation | 23 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch OLO
Get an email the morning anything changes in OLO — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.