510(k) · Cleared
ClearedRemex Spine Surgery Navigation System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remex Medical Corp. · OLO Orthopedic Stereotaxic Instrument
Cleared on May 1, 2024 as substantially equivalent to K230783 (Remex Medical Corp., 2023) and 2 other predicates after a 182-day review. Its family tree reaches back 5 generations to 2005. 4 later devices descend from it.
- Decided
- May 1, 2024
- Review
- 182 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K050438 (2005). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 4 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- 3 generations backK180523 INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
- 2 generations backK220348 Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S…Remex Medical Corporation · 2022
- 1 generation backK230783 Anatase Spine Surgery Navigation SystemRemex Medical Corp. · 2023
- This deviceK233513 Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2024
- Descendant · cites it directly · 1 of its ownK251315 Anatase Spine Surgery Navigation System and Remex Spine Surgery…Remex Medical Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK262506 Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026
- Descendant · cites it directly · 0 of its ownK243560 Remex Spine Surgery Navigation InstrumentRemex Medical Corp. · 2024
- Descendant · cites it directly · 0 of its ownK241625 Anatase Navi Disposable InstrumentRemex Medical Corp. · 2024
Most influential descendants
Showing 4 of 4 · See all- K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2025 · cites it directly1descendant
- K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026 · 2 generations on0descendants
- K243560Remex Spine Surgery Navigation InstrumentRemex Medical Corp. · 2024 · cites it directly0descendants
- K241625Anatase Navi Disposable InstrumentRemex Medical Corp. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −4 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| −3 | K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019 | — |
| −2 | K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and… | Remex Medical Corporation | 2022 | — |
| −1 | K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | 2023 | — |
| 0 (this device) | K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024 | — |
| +1 | K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation… | Remex Medical Corp. | 2025 | — |
| +2 | K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026 | — |
| +1 | K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024 | — |
| +1 | K241625 | Anatase Navi Disposable Instrument | Remex Medical Corp. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230783 | Anatase Spine Surgery Navigation System Our reading of the summary gave K230738, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Anatase Spine Surgery Navigation System (primary)”. | 2023 |
| * | K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VSummary page 4…OLO Device Class Class II Predicate Devices K230738, Anatase Spine Surgery Navigation System (primary) Information K220348, Anatase Spine Surgery Navigation System K180523, INTAI Surgery Navigation System Device Desc… | 2022 |
| * | K180523 | INTAI Surgery Navigation SystemSummary page 4…30738, Anatase Spine Surgery Navigation System (primary) Information K220348, Anatase Spine Surgery Navigation System K180523, INTAI Surgery Navigation System Device Description The Remex Spine Surgery Navigation System II, also known as… | 2019 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K251315 (Remex Medical Corp., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K230783.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Remex Spine Surgery Navigation System I, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233513: Remex Spine Surgery Navigation System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233513
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026