510(k) · Cleared
ClearedTELIGEN System Navigation Ready Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · OLO Orthopedic Stereotaxic Instrument
Cleared on Jun 14, 2024 as substantially equivalent to K223108 (Medos International SARL, 2023) and 1 other predicate after a 260-day review. Its family tree reaches back 10 generations to 1999. 3 of the 27 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 14, 2024
- Review
- 260 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K983831 (1999). 24 ancestors in all, the oldest K981508 (1998). 2 later devices descend from it, 1 citing it directly. 3 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 6 generations between
- 3 generations backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- 2 generations backK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- 1 generation backK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
- This deviceK233254 TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
- Descendant · cites it directly · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · 2 generations on · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
Show all 10 generations
- Root · 10 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 9 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 8 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 7 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 6 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 5 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 4 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 3 generations backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- 2 generations backK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- 1 generation backK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
- This deviceK233254 TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −9 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −8 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −7 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −6 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −5 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −4 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −3 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| −2 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
| −1 | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN… | Medos International SARL | 2023 | — |
| 0 (this device) | K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024 | — |
| +1 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +2 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Summary page 5…PDQ – Neurology D. Predicate Device Names Primary Predicate Device: TELIGEN System Navigation Ready Indications – K223108 – OLO Additional Predicate Device: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set – K21… | 2023 |
| * | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetSummary page 5…stem Navigation Ready Indications – K223108 – OLO Additional Predicate Device: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set – K212756 – OLO Page 1 of 5 K233254 E… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | 2024 | 1 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K070106VV Fluoro 3DBrainlab AG · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 24 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K241893 (Medos International SARL, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K223108.
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?
TELIGEN Navigation Ready Instruments: The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine. The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous…
Read the full statement (540 words)
TELIGEN Navigation Ready Instruments:
The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.
The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used Iin surgical spinal procedures, in which:
* the use of stereotactic surgery may be appropriate, and
* reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion.
TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be pre-calibrated with:
* the VELYS Spine System using the VELYS Spine Instrument Arrays,
« the Brainlab Navigation System using the UNAS Arrays.
TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.
The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.
Discectomy Navigation Ready Instruments:
The Discectomy Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which:
* the use of stereotactic surgery may be appropriate, and
* reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays.
These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.
Universal Navigation Adaptor Set:
The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:
* the use of stereotactic surgery may be appropriate, and
* reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:
* pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays,
* pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
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/K233254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233254: TELIGEN System Navigation Ready Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233254
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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