510(k) · Cleared
ClearedTELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · OLO Orthopedic Stereotaxic Instrument
Cleared on Jan 19, 2023 as substantially equivalent to K122211 (Synthes Spine, 2012) and 1 other predicate after a 111-day review. Its family tree reaches back 9 generations to 1999. 3 of the 28 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Jan 19, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K983831 (1999). 23 ancestors in all, the oldest K981508 (1998). 4 later devices descend from it, 2 citing it directly. 3 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations between
- 3 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 2 generations backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- 1 generation backK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- This deviceK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
- Descendant · cites it directly · 2 of its ownK233254 TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024
- Descendant · 2 generations on · 1 of its ownK241893 CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024
- Descendant · 3 generations on · 0 of its ownK254157 CROSSNAV Navigation Enabled Instruments for Disc Preparation and…Medos International SARL · 2026
- Descendant · cites it directly · 0 of its ownK223438 TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL · 2023
Show all 9 generations
- Root · 9 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 8 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 7 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 6 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 5 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 4 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 3 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 2 generations backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- 1 generation backK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- This deviceK223108 TELIGEN System Navigation Ready Indications (TELIGEN Access Probe…Medos International SARL · 2023
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K233254TELIGEN System Navigation Ready InstrumentsDePuy Synthes · 2024 · cites it directly2descendants
- K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL · 2024 · 2 generations on1descendant
- K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL · 2026 · 3 generations on0descendants
- K223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −8 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −7 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −6 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −5 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −4 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −3 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −2 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| −1 | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2022 | — |
| 0 (this device) | K223108 | TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN… | Medos International SARL | 2023 | — |
| +1 | K233254 | TELIGEN System Navigation Ready Instruments | DePuy Synthes | 2024 | — |
| +2 | K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Medos International SARL | 2024 | — |
| +3 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | 2026 | — |
| +1 | K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K122211 | Synthes Navigable Pedicle Preparation InstrumentsSummary page 4…Panel Code HRX – Orthopedic D. Predicate Device Names Primary Predicate Device: Synthes Navigable Pedicle Preparation Instruments (K122211) – HAW, OLO Additional Predicate Devices: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set… | 2012 |
| * | K212756 | Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetSummary page 4…ation Instruments (K122211) – HAW, OLO Additional Predicate Devices: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (UNAS) (K212756) – OLO Page 1 of 3 Reference Device: TELIGEN System (K213978)… | 2022 |
| † | K213978 | TELIGEN System | 2022 |
| † | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection… | 2022 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 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 24 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 23 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K233254 (DePuy Synthes, 2024) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K122211.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 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 in…
Read the full statement (185 words)
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 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. TELIGEN Clear, when used with UNAS, can be pre-calibrated with the Brainlab Navigation System. TELIGEN Access Probe, when used with UNAS, can be pre-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 as stated in the FDA summary.
https://510kreport.com/device/K223108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223108: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223108
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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