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 29, 2019 as substantially equivalent to K122211 (Synthes Spine, 2012) and 1 other predicate after an 83-day review. Its family tree reaches back 8 generations to 2000. 1 of the 34 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 29, 2019
- Review
- 83 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K002053 (2000). 33 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 1 of the 34 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK002053 Navitrak System-Optical Option, Model 900.004Orthosoft, Inc. · 2000
- 7 generations backK021760 Navitrack System-Optical TKR CT-Less, Model 900.120Orthosoft, Inc. · 2002
- 6 generations backK043536 Navitrack System - S&N Image Free KneeOrthosoft, Inc. · 2005
- 5 generations backK060556 Brigit Surgical DeviceZimmer, Inc. · 2006
- 4 generations backK092239 Rosa Surgical Device, Model Rosa 1.1Medtech S.A · 2009 · Recalled
- 3 generations backK101791 Rosa Surgical DeviceMedtech S.A.S · 2010 · Recalled
- 2 generations backK151511 ROSA SpineMedtech S.A · 2016 · Recalled
- 1 generation backK182848 ROSA ONE Spine applicationMedtech S.A · 2019
- This deviceK192133 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 |
|---|---|---|---|---|---|
| −8 | K002053 | Navitrak System-Optical Option, Model 900.004 | Orthosoft, Inc. | 2000 | — |
| −7 | K021760 | Navitrack System-Optical TKR CT-Less, Model 900.120 | Orthosoft, Inc. | 2002 | — |
| −6 | K043536 | Navitrack System - S&N Image Free Knee | Orthosoft, Inc. | 2005 | — |
| −5 | K060556 | Brigit Surgical Device | Zimmer, Inc. | 2006 | — |
| −4 | K092239 | Rosa Surgical Device, Model Rosa 1.1 | Medtech S.A | 2009 | 9 |
| −3 | K101791 | Rosa Surgical Device | Medtech S.A.S | 2010 | 12 |
| −2 | K151511 | ROSA Spine | Medtech S.A | 2016 | 3 |
| −1 | K182848 | ROSA ONE Spine application | Medtech S.A | 2019 | — |
| 0 (this device) | K192133 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2012 | 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 K182848 ROSA One Spine Navigation System Referenc… | 2012 |
| * | K182848 | ROSA ONE Spine applicationSummary page 4…CFR 882.4560) Device Panel Orthopedic Primary Predicate K122211 Synthes Navigable Pedicle Preparation Instruments Secondary Predicate K182848 ROSA One Spine Navigation System Reference Devices K133444 Medtronic StealthStation K132884… | 2019 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
| † | K132884 | Pathfinder NXT Minimally Invasive Pedicle Screw System | 2013 |
| † | K151974 | Polaris Spinal System | 2015 |
| † | K183550 | Vitality® Spinal Fixation System | 2019 |
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 · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 33 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. The universal adaptors are specifically designed for use with the Zimmer Biomet ROSA One Spine System, which is indicated for providing spatial positioning and orientation of instrument holders…
Read the full statement (120 words)
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. The universal adaptors are specifically designed for use with the Zimmer Biomet ROSA One Spine System, which is indicated for providing spatial positioning and orientation of instrument holders or tool guides based upon an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The ROSA One Spine System is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192133: 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/K192133
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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