510(k) · Cleared
ClearedRemex Spine Surgery Navigation Instrument
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 Dec 13, 2024 as substantially equivalent to K233513 (Remex Medical Corp., 2024) and 1 other predicate after a 25-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Dec 13, 2024
- Review
- 25 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K050438 (2005). No later device cites it as a predicate yet.
- Root · 6 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 5 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- 4 generations backK180523 INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
- 3 generations backK220348 Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S…Remex Medical Corporation · 2022
- 2 generations backK230783 Anatase Spine Surgery Navigation SystemRemex Medical Corp. · 2023
- 1 generation backK233513 Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2024
- This deviceK243560 Remex Spine Surgery Navigation InstrumentRemex Medical Corp. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −5 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| −4 | K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019 | — |
| −3 | K220348 | Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and… | Remex Medical Corporation | 2022 | — |
| −2 | K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | 2023 | — |
| −1 | K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024 | — |
| 0 (this device) | K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024 | — |
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? (2)
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 |
|---|---|---|---|
| * | K233513 | Remex Spine Surgery Navigation System IISummary page 4…ibe) The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning… | 2024 |
| * | K230783 | Anatase Spine Surgery Navigation SystemSummary page 4…ry Navigation Instrument Indications for Use (Describe) The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navig… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K233513.
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 instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be…
Read the full statement (120 words)
The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine 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, with the lumbar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243560: Remex Spine Surgery Navigation Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243560
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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