510(k) · Cleared
ClearedOptiVu™ Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mr Surgical Solutions, LLC · SBF Orthopedic Augmented Reality
Cleared on Jul 9, 2025 as substantially equivalent to K243975 (Pixee Medical, 2025) and 2 other predicates after a 174-day review. Its family tree reaches back 17 generations to 1991. 2 of the 267 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 9, 2025
- Review
- 174 days
- Class
- Class II
- Product code
- SBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K905070 (1991). 266 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly. 2 of the 267 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations between
- 3 generations backK221928 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
- 2 generations backK230243 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2023
- 1 generation backK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- This deviceK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
- Descendant · cites it directly · 0 of its ownK252170 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
Show all 17 generations
- Root · 17 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 16 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 15 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 14 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 13 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 12 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 11 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 10 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 9 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 8 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 7 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 6 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 5 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 4 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 3 generations backK221928 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
- 2 generations backK230243 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2023
- 1 generation backK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- This deviceK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K252170OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −16 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −15 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −14 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −13 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −12 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −11 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −10 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −9 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −8 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −7 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −6 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −5 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| −4 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −3 | K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2022 | — |
| −2 | K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2023 | — |
| −1 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
| 0 (this device) | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
| +1 | K252170 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 15 | 0 |
| 2001 | 16 | 0 |
| 2002 | 16 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 14 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 1 |
| 2016 | 4 | 1 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
2 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 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? (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 |
|---|---|---|---|
| * | K243975 | Knee+ Cleared while this submission was under review Summary page 5…e Classification: Class II Reviewing Panel: Orthopedic Product Codes: SBF Primary Predicate Device: Pixee Medical Knee+ (K243975) Additional Predicate Devices: Medacta International SA NextAR RSA Platform (K210153) Orthosoft Inc… | 2025 |
| * | K210153 | NextAR RSA PlatformSummary page 5…uct Codes: SBF Primary Predicate Device: Pixee Medical Knee+ (K243975) Additional Predicate Devices: Medacta International SA NextAR RSA Platform (K210153) Orthosoft Inc (d/b/a Zimmer CAS) ROSA® Shoulder System (K233199) Device Description: OptiVu Sho… | 2021 |
| * | K233199 | ROSA® Shoulder SystemSummary page 5…dditional Predicate Devices: Medacta International SA NextAR RSA Platform (K210153) Orthosoft Inc (d/b/a Zimmer CAS) ROSA® Shoulder System (K233199) Device Description: OptiVu Shoulder is a stereotaxic surgical navigation system designed to aid surgeons in locating anatomic… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252170 | OptiVu™ Shoulder | 2025 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 34 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 82 of the 265 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K252170 (Mr Surgical Solutions, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K243975.
How does its category compare?
All SBF devicesSBF Orthopedic Augmented Reality: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient’s preoperative CT scan. OptiVu Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu Shoulder is…
Read the full statement (173 words)
OptiVu Shoulder is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient’s preoperative CT scan.
OptiVu Shoulder utilizes pre-operative planning files provided by the Zimmer CAS Signature ONE™ System. OptiVu Shoulder is compatible with any humeral implants that are supported by the Signature ONE™ System.
OptiVu Shoulder is specifically indicated for total shoulder arthroplasty using the Zimmer Biomet Alliance® Glenoid system or reverse shoulder arthroplasty using the Comprehensive® Reverse Shoulder system, to aid the surgeon in locating anatomical structures (humerus and scapula), humerus resection, and aligning the glenoid component with the anatomical structures.
OptiVu Shoulder includes an augmented reality (AR) head-mounted display (HMD) (OptiVu Tilt with HoloLens 2) and trackers to register and optically track anatomical landmarks and surgical instruments in real-time during the procedure. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250108: OptiVu™ Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250108
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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