510(k) · Cleared
ClearedROSA® Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft D/B/A Zimmer Cas · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 4, 2022 as substantially equivalent to K182964 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) after a 95-day review. Its family tree reaches back 14 generations to 1991. 8 later devices descend from it.
- Decided
- Oct 4, 2022
- Review
- 95 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K905070 (1991). 59 ancestors in all, the oldest K811452 (1981). 8 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations between
- 3 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 2 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 1 generation backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- This deviceK221928 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
- Descendant · cites it directly · 6 of its ownK230243 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2023
- Descendant · 2 generations on · 3 of its ownK233199 ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024
- Descendant · 3 generations on · 1 of its ownK250108 OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025
- Descendant · 2 generations on · 1 of its ownK242864 ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2024
- Descendant · 3 generations on · 0 of its ownK260582 ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026
Show all 14 generations
- Root · 14 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 13 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 12 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 9 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 8 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 7 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 6 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 5 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 4 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 3 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 2 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 1 generation backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- This deviceK221928 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K230243ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2023 · cites it directly6descendants
- K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2024 · 2 generations on3descendants
- K250108OptiVu™ ShoulderMr Surgical Solutions, LLC · 2025 · 3 generations on1descendant
- K242864ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2024 · 2 generations on1descendant
- K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −13 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −12 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −9 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −8 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −7 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −6 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −5 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −4 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −3 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −2 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| −1 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| 0 (this device) | K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2022 | — |
| +1 | K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2023 | — |
| +2 | K233199 | ROSA® Shoulder System | Orthosoft Inc (D/B/A Zimmer Cas) | 2024 | — |
| +3 | K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025 | — |
| +2 | K242864 | ROSA® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024 | — |
| +3 | 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 |
|---|---|---|
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K182964 | ROSA Knee SystemSummary page 4…ice: Manufacturer Device Name 510(k) Number Zimmer CAS ROSA® Knee K182964 System Purpose and Device Description: The ROS… | 2019 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 59 ancestors have a recall of any class.
- Of its descendants, K230243 (Orthosoft D/B/A Zimmer Cas, 2023) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K182964.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Knee System, for use with the ROSA® RECON Platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to anatomical landmarks as recorded using…
Read the full statement (192 words)
The ROSA Knee System, for use with the ROSA® RECON Platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray or MRI based surgical planning tools.
It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.
The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.
The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona IQ®, Vanguard® CR, and Vanguard PS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221928: ROSA® Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221928
Report an extraction error
Are you the manufacturer?
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