510(k) · Cleared
ClearedZimmer Biomet Universal Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 24, 2019 as substantially equivalent to K122211 (Synthes Spine, 2012) and 1 other predicate after a 233-day review. Its family tree reaches back 6 generations to 1999. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 24, 2019
- Review
- 233 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K983831 (1999). 14 ancestors in all, the oldest K981508 (1998). No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 5 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 4 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 3 generations backK053159 Vectorvision SpineBrainlab AG · 2006 · Recalled
- 2 generations backK070106 VV Fluoro 3DBrainlab AG · 2007 · Recalled (Class I)
- 1 generation backK122211 Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
- This deviceK190556 Zimmer Biomet Universal Navigation SystemZimmer Biomet Spine, Inc. · 2019
Class I recalls in this family
- K070106 VV Fluoro 3D2 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −5 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −4 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −3 | K053159 | Vectorvision Spine | Brainlab AG | 2006 | 1 |
| −2 | K070106 | VV Fluoro 3D | Brainlab AG | 2007 | Class I |
| −1 | K122211 | Synthes Navigable Pedicle Preparation Instruments | Synthes Spine | 2012 | — |
| 0 (this device) | K190556 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 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.
1 device in this family has 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…Class II Classification Name OLO – Orthopedic Stereotaxic Instrument (21 CFR 882.4560) Device Panel Orthopedic Primary Predicate K122211 Synthes Navigable Pedicle Preparation Instruments Secondary Predicate K133444 Medtronic StealthStation Reference Devices… | 2012 |
| * | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation SystemSummary page 4…(21 CFR 882.4560) Device Panel Orthopedic Primary Predicate K122211 Synthes Navigable Pedicle Preparation Instruments Secondary Predicate K133444 Medtronic StealthStation Reference Devices K132884 Pathfinder NXT Spine System K151974 Polar… | 2014 |
| † | K132884 | Pathfinder NXT Minimally Invasive Pedicle Screw System | 2013 |
| † | K151974 | Polaris Spinal System | 2015 |
| † | K171907 | Vitality® Spinal Fixation System | 2017 |
| † | K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2019, 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 Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors are specifically designed for use with the Medtronic StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190556: Zimmer Biomet Universal Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190556
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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