510(k) · Cleared
ClearedROSA Knee 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 Jan 24, 2019 as substantially equivalent to K151511 (Medtech S.A, 2016) and 1 other predicate after a 91-day review. Its family tree reaches back 13 generations to 1991. 29 later devices descend from it.
- Decided
- Jan 24, 2019
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K905070 (1991). 58 ancestors in all, the oldest K811452 (1981). 29 later devices descend from it, 8 citing it directly.
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations between
- 3 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 2 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- This deviceK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · cites it directly · 10 of its ownK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 9 of its ownK232802 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023
- Descendant · 3 generations on · 8 of its ownK241031 TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. · 2024
- Descendant · cites it directly · 8 of its ownK221928 ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022
- Descendant · 4 generations on · 7 of its ownK242264 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 12 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 11 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 10 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 8 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 7 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 6 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 5 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 4 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 3 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 2 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- This deviceK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · cites it directly10descendants
- K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 2 generations on9descendants
- K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. · 2024 · 3 generations on8descendants
- K221928ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas · 2022 · cites it directly8descendants
- K242264TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2024 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −12 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −11 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −10 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −8 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −7 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −6 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −5 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −4 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −3 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −2 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −1 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| 0 (this device) | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +1 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 1 |
| +2 | K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | — |
| +3 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | 2024 | — |
| +1 | K221928 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | 2022 | — |
| +4 | K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | — |
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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K151511 | ROSA SpineSummary page 4…882.4560) Predicate Device(s): Manufacturer Device Name 510(k) Number Medtech S.A. ROSA Spine K151511 MAKO Surgical Mako Total Knee K172219 Corp. Application Purpose and Device Descrip… | 2016 |
| * | K172219 | Mako Total Knee ApplicationSummary page 4…Manufacturer Device Name 510(k) Number Medtech S.A. ROSA Spine K151511 MAKO Surgical Mako Total Knee K172219 Corp. Application Purpose and Device Description: The ROSA® Knee System is used t… | 2017 |
What descends from it? (29)
See all 298 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230202 | TMINI™ Miniature Robotic System | 2023 | 10 |
| K221928 | ROSA® Knee System | 2022 | 8 |
| K220733 | OptiVu ROSA MxR | 2022 | 1 |
| K210998 | ROSA Hip System | 2021 | 1 |
| K210121 | ROSA Partial Knee System | 2021 | 1 |
| K252058 | ROSA Knee System with UltraSound Imaging Platform (USIP) | 2026 | 0 |
| K213873 | SkyWalker Total Knee System | 2022 | 0 |
| K213708 | ROSA® Knee System | 2022 | 0 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 17 of the 58 ancestors have a recall of any class.
- Of its descendants, K230202 (THINK Surgical, Inc., 2023) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K151511.
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 ROSA® Knee System 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…
Read the full statement (165 words)
The ROSA® Knee System 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 sensor navigation system and accessories, software system, surgical instruments and accessories.
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, Vanguard® CR, and Vanguard PS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182964: ROSA Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182964
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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