510(k) · Cleared
Recalled · Class II · 2024Mako Total Knee Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corp. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 14, 2020 as substantially equivalent to K191998 (Mako Surgical Corp., 2019) after a 208-day review. Its family tree reaches back 15 generations to 1991. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jul 14, 2020
- Review
- 208 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 15 generations to K905070 (1991). 57 ancestors in all, the oldest K861692 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations between
- 3 generations backK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- 2 generations backK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- This deviceK193515 Mako Total Knee ApplicationMako Surgical Corp. · 2020
- Descendant · cites it directly · 0 of its ownK240721 ExcelsiusFlex™Globus Medical, Inc. · 2024
Show all 15 generations
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 14 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 13 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 10 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 9 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 8 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 7 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 6 generations backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 5 generations backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- 4 generations backK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 3 generations backK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- 2 generations backK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- 1 generation backK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- This deviceK193515 Mako Total Knee ApplicationMako Surgical Corp. · 2020
Most influential descendants
Showing 1 of 1 · See all- K240721ExcelsiusFlex™Globus Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −14 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −13 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −10 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −9 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −8 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −7 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −6 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| −5 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| −4 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| −3 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| −2 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| −1 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| 0 (this device) | K193515 | Mako Total Knee Application | Mako Surgical Corp. | 2020 | — |
| +1 | K240721 | ExcelsiusFlex™ | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K191998 | Mako Total Hip Application, Mako Total Knee ApplicationSummary page 4…quivalence Claimed To: The subject device, the Mako Total Knee Application, is substantially equivalent to the predicate device, Mako Total Knee Application, cleared via K191998. In addition, the alignment methods and alignment limits for the subject Mako Total Knee Application are substantially equivalen… | 2019 |
| † | K201343 | Triathlon Total KneeSystem | 2020 |
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 |
|---|---|---|---|
| K240721 | ExcelsiusFlex™ | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2024 | Class II | Z-1912-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1910-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1911-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1914-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1913-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
| Apr 15, 2024 | Class II | Z-1915-2024 | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 17 of the 57 ancestors have a recall of any class.
- Of its descendants, K240721 (Globus Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K191998.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures…
Read the full statement (107 words)
The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Mako System is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
» Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
* Triathlon Total Knee System (CR/CS/PS/PSR cemented and cementless primary)
* Triathlon Total Knee System (TS inserts cemented primary)
* Kinetis Total Knee System (CR/UC)
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/K193515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193515: Mako Total Knee Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193515
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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