510(k) · Cleared
Recalled · Class II · 2017Mako 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 May 11, 2017 as substantially equivalent to K143752 (Mako Surgical Corp., 2015) after a 72-day review. Its family tree reaches back 11 generations to 1991. 38 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2017
- Review
- 72 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K905070 (1991). 40 ancestors in all, the oldest K861692 (1986). 38 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 7 generations between
- 3 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 1 generation backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- This deviceK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- Descendant · cites it directly · 37 of its ownK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- Descendant · 2 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 3 generations on · 10 of its ownK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
- Descendant · 4 generations on · 9 of its ownK232802 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023
- Descendant · 5 generations on · 8 of its ownK241031 TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 10 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 9 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 6 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 5 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 4 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 3 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 1 generation backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- This deviceK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K172219Mako Total Knee ApplicationMako Surgical Corp. · 2017 · cites it directly37descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 2 generations on29descendants
- K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 3 generations on10descendants
- K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 4 generations on9descendants
- K241031TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. · 2024 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −10 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −9 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −6 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −5 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −4 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −3 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −2 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −1 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| 0 (this device) | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| +1 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| +2 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +3 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 1 |
| +4 | K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | — |
| +5 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, 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 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K143752 | Total Knee Application (TKA)Summary page 4…de: OLO Substantial Equivalence Claimed To: The Mako Total Knee Application is substantially equivalent to the Mako Total Knee Application cleared via K143752. Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being impl… | 2015 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172219 | Mako Total Knee Application | 2017 | 37 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2017 | Class II | Z-3182-2018 | Nonconforming Material/Component | Communication-connection error. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 10 of the 40 ancestors have a recall of any class.
- Of its descendants, K172219 (Mako Surgical Corp., 2017) has gone furthest, with 37 descendants of its own.
- 2 other devices also cite its predicate K143752.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 include:
• Total Knee Arthroplasty (TKA)
The implants systems compatible with this system:
• Triathlon Total Knee System (CR/CS/PS cemented Primary)
• Kinetis Total Knee System (CR/UC)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170581: 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/K170581
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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