510(k) · Cleared
ClearedROSA® Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft Inc. (d/b/a) Zimmer CAS · OLO Orthopedic Stereotaxic Instrument
Cleared on May 21, 2026 as substantially equivalent to K233199 (Orthosoft Inc (D/B/A Zimmer Cas), 2024) after a 90-day review. Its family tree reaches back 17 generations to 1991.
- Decided
- May 21, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K905070 (1991). 159 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- 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 deviceK260582 ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
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 deviceK260582 ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
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) | K260582 | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 8 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 13 | 0 |
| 2005 | 12 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 OLO? 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? (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 |
|---|---|---|---|
| * | K233199 | ROSA® Shoulder SystemSummary page 5…4560 Product Code(s) OLO, LLZ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233199 ROSA® Shoulder System OoLO Device Description Summary 21 CFR 807.92(a)(4) The ROSA® Shoulder system (RSS) for use with ROSA® REC… | 2024 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 39 of the 159 ancestors have a recall of any class.
- 1 other device also cites its predicate K233199.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 ROSA Shoulder System, for use with the ROSA Recon Platform, is indicated as a stereotaxic instrument system for total shoulder arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components. The Robotic Arm placement is performed relative to anatomical landmarks and bony…
Read the full statement (187 words)
The ROSA Shoulder System, for use with the ROSA Recon Platform, is indicated as a stereotaxic instrument system for total shoulder arthroplasty (TSA) surgery. It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference to identifiable anatomical structures for the accurate placement of the shoulder implant components.
The Robotic Arm placement is performed relative to anatomical landmarks and bony anatomy as recorded using the system intra-operatively, and based on a three-dimensional representation of the bone structures determined pre-operatively using compatible CT-based imaging technology.
It includes a Robotic Arm, an Optical Sensor navigation system and accessories, software system, surgical instruments and accessories.
The ROSA Shoulder System is designed for a skeletally mature patient population. The target population has the same characteristics as the population targeted by the implants compatible with the ROSA Shoulder System.
The ROSA Shoulder System is to be used with the following shoulder replacement systems per their indications and contraindications:
* Humerus implants: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Identity® Shoulder System and Identity® Reverse Shoulder System
* Glenoid implants: Alliance® Glenoid and Comprehensive® Reverse Shoulder System
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/K260582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260582: ROSA® Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260582
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026