510(k) · Cleared
ClearedDiscectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
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 May 5, 2022 as substantially equivalent to K201661 (Medos International SARL, 2020) and 2 other predicates after a 247-day review. Its family tree reaches back 8 generations to 1999. 3 of the 28 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- May 5, 2022
- Review
- 247 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K983831 (1999). 22 ancestors in all, the oldest K981508 (1998). 5 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 · 8 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 7 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 6 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 5 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 4 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 3 generations backK083310 Spine & Trauma IctBrainlab AG · 2009
- 2 generations backK183605 Spine & Trauma NavigationBrainlab AG · 2019 · Recalled
- 1 generation backK201661 Symphony Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2020
- This deviceK212756 Discectomy Navigation Ready Instruments and Universal Navigation…Medos International SARL · 2022
- Descendant · cites it directly · 4 of its ownK223108 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 · 2 generations on · 0 of its ownK223438 TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARL · 2023
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K223108TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL · 2023 · cites it directly4descendants
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −7 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −6 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −5 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −4 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −3 | K083310 | Spine & Trauma Ict | Brainlab AG | 2009 | — |
| −2 | K183605 | Spine & Trauma Navigation | Brainlab AG | 2019 | 3 |
| −1 | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set | Medos International SARL | 2020 | — |
| 0 (this device) | 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 | — |
| +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 | — |
| +2 | 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 | 2 | 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? (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 |
|---|---|---|---|
| * | K201661 | Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetSummary page 4…dic Panel Code: D. Predicate Device Names Primary Predicate Device: SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set (K201661) Additional Predicate Devices: Synthes Navigable Pedicle Preparation Instruments (K122211) Brainlab Spine & Traum… | 2020 |
| * | K122211 | Synthes Navigable Pedicle Preparation InstrumentsSummary page 4…igation Ready Instruments and Universal Navigation Adaptor Set (K201661) Additional Predicate Devices: Synthes Navigable Pedicle Preparation Instruments (K122211) Brainlab Spine & Trauma Navigation System (K212245)… | 2012 |
| * | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection… Cleared while this submission was under review Summary page 4…daptor Set (K201661) Additional Predicate Devices: Synthes Navigable Pedicle Preparation Instruments (K122211) Brainlab Spine & Trauma Navigation System (K212245) K212756 - Page 2 of 4 E. Devi… | 2022 |
What descends from it? (5)
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 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 22 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K223108 (Medos International SARL, 2023) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K201661.
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 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…
Read the full statement (276 words)
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 Brainlab Navigation System.
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 Instrument, when used with UNAS, can be 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 as stated in the FDA summary.
https://510kreport.com/device/K212756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212756
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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