510(k) · Cleared
ClearedSkyWalker Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Navibot International, LLC · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 7, 2022 as substantially equivalent to K182964 (Orthosoft Inc (D/B/A Zimmer Cas), 2019) after a 206-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Jul 7, 2022
- Review
- 206 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). No later device cites it as a predicate yet.
- 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 deviceK213873 SkyWalker Total Knee SystemMicroport Navibot International, LLC · 2022
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 deviceK213873 SkyWalker Total Knee SystemMicroport Navibot International, LLC · 2022
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) | K213873 | SkyWalker Total Knee System | Microport Navibot International, LLC | 2022 | — |
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 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…Substantial Equivalence Claimed To The subject device, SkyWalker Total Knee System, is substantially equivalent to the predicate device, ROSA Knee System, cleared under K182964. 2. Indications for Use SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) p… | 2019 |
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 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.
- 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?
SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components. It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with…
Read the full statement (172 words)
SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components.
It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with a CT based model.
SkyWalker Total Knee System includes surgical console (a robotic arm platform), navigation console (an optical tracking navigation platform), software system (including preoperative planning software), cables, surgical instruments and accessories. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a preoperative plan derived from imported CT images.
The targeted population as well as indications and contraindications have the same characteristics as those suitable for the following implants compatible with SkyWalker Total Knee System: EVOLUTION® MP TOTAL KNEE SYSTEM, EVOLUTION® MP TOTAL KNEE SYSTEM, ADVANCE® STATURE FEMORAL COMPONENT, ADVANCE® TIBIAL COMPONENT, and ADVANCE® KNEE SYSTEM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213873: SkyWalker Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213873
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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