510(k) · Cleared
ClearedOptiVu™ ROSA® MxR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft Inc (D/B/A Zimmer Cas) · SBF Orthopedic Augmented Reality
Cleared on Jun 13, 2023 as substantially equivalent to K220733 (Orthosoft Inc (D/B/A Zimmer Cas), 2022) after a 104-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Jun 13, 2023
- Review
- 104 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K905070 (1991). 60 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet.
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations between
- 3 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 2 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK220733 OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas) · 2022
- This deviceK230567 OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas) · 2023
Show all 15 generations
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 14 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 13 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 10 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 9 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 8 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 7 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 6 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 5 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 4 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 3 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 2 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK220733 OptiVu ROSA MxROrthosoft Inc (D/B/A Zimmer Cas) · 2022
- This deviceK230567 OptiVu™ ROSA® MxROrthosoft Inc (D/B/A Zimmer Cas) · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −14 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −13 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −10 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −9 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −8 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −7 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −6 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −5 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −4 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −3 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| −2 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −1 | K220733 | OptiVu ROSA MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2022 | — |
| 0 (this device) | K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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.
Planning a device in SBF? 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 SBF device
- #1 K193559 NextAR TKA Platformscore 20.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K220733 | OptiVu ROSA MxRSummary page 4…(21 CFR 892.2050) Predicate Device: 510(k) Device Name Manufacturer Predicate Number K220733 OptiVu™ ROSA® MxR Zimmer CAS Primary Purpose and Device Description:… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 17 of the 60 ancestors have a recall of any class.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · SBF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SBF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SBF
1in 2025
MAUDE reports naming product code SBF, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 162 | 0 | 0 |
| 2022 | 7 | 234 | 0 | 0 |
| 2023 | 7 | 104 | 0 | 0 |
| 2024 | 6 | 89 | 0 | 0 |
| 2025 | 13 | 90 | 1 | 1 |
| 2026 | 3 | 123 | 1 | — |
What is it indicated for?
OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230567: OptiVu™ ROSA® MxR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230567
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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