510(k) · Cleared
ClearedAnatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remex Medical Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 14, 2022 as substantially equivalent to K180523 (Intai Technology Corporation, 2019) after a 157-day review. Its family tree reaches back 3 generations to 2005. 6 later devices descend from it.
- Decided
- Jul 14, 2022
- Review
- 157 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K050438 (2005). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 2 generations backK133444 Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation…Medtronic Navigation, Inc. · 2014 · Recalled
- 1 generation backK180523 INTAI Surgery Navigation SystemIntai Technology Corporation · 2019
- This deviceK220348 Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S…Remex Medical Corporation · 2022
- Descendant · cites it directly · 5 of its ownK230783 Anatase Spine Surgery Navigation SystemRemex Medical Corp. · 2023
- Descendant · cites it directly · 4 of its ownK233513 Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2024
- Descendant · 2 generations on · 1 of its ownK251315 Anatase Spine Surgery Navigation System and Remex Spine Surgery…Remex Medical Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK262506 Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK243560 Remex Spine Surgery Navigation InstrumentRemex Medical Corp. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230783Anatase Spine Surgery Navigation SystemRemex Medical Corp. · 2023 · cites it directly5descendants
- K233513Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2024 · cites it directly4descendants
- K251315Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System IIRemex Medical Corp. · 2025 · 2 generations on1descendant
- K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp. · 2026 · 3 generations on0descendants
- K243560Remex Spine Surgery Navigation InstrumentRemex Medical Corp. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −2 | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | Medtronic Navigation, Inc. | 2014 | 1 |
| −1 | K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | 2019 | — |
| 0 (this device) | 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 | — |
| +1 | K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024 | — |
| +2 | K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation… | Remex Medical Corp. | 2025 | — |
| +3 | K262506 | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | 2026 | — |
| +2 | K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K180523 | INTAI Surgery Navigation SystemSummary page 5…ereotaxic instrument Regulation Number: 882.4560 Product Code: OLO Device Class: Class 2 Panel: Stereotaxic, Trauma and Restorative Devices (DHT6C) PREDICATE DEVICE: K180523, INTAI Surgery Navigation System, Intai Technology Corporation Page 1 of 6 Remex Medical Corporation 4F, No. 9,… | 2019 |
| † | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | 2017 |
| † | K172548 | Wiltrom Spinal Fixation System | 2018 |
| † | K132884 | Pathfinder NXT Minimally Invasive Pedicle Screw System | 2013 |
| † | K113529 | CD Horizon Voyager Spinal System | 2012 |
| † | K150231 | Navigated Disc Prep Instruments and CAPSTONE Trials | 2015 |
What descends from it? (6)
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 17 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K230783 (Remex Medical Corp., 2023) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K180523.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Anatase Spine Surgery Navigation System 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 but are not limited to:
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/K220348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220348: Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220348
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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