510(k) · Cleared
Recalled · Class II · 2019Total Knee Application (TKA)
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 Aug 6, 2015 as substantially equivalent to K112507 (Mako Surgical Corporation, 2012) after a 218-day review. Its family tree reaches back 10 generations to 1991. 44 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 6, 2015
- Review
- 218 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 10 generations to K905070 (1991). 39 ancestors in all, the oldest K861692 (1986). 44 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 6 generations between
- 3 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- This deviceK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015
- Descendant · cites it directly · 38 of its ownK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 2 generations on · 37 of its ownK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- Descendant · 3 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 4 generations on · 10 of its ownK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
- Descendant · 5 generations on · 9 of its ownK232802 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 9 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 8 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 7 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 5 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 4 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 3 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 2 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- This deviceK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K170581Mako Total Knee ApplicationMako Surgical Corp. · 2017 · cites it directly38descendants
- K172219Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 2 generations on37descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 3 generations on29descendants
- K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 4 generations on10descendants
- K232802TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −9 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −8 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −7 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −5 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −4 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −3 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −2 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −1 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| 0 (this device) | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | — |
| +1 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| +2 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| +3 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +4 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 1 |
| +5 | K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 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 |
|---|---|---|---|
| * | K112507 | Restoris Partial Knee Application (Pka), Rio Standard SystemSummary page 4…Total Knee Application is substantially equivalent to MAKO Surgical Corp.’s (Robotic Arm Interactive Orthopedic System) RIO® – (Partial Knee Application) PKA cleared via K112507. Description: The Robotic Arm Interactive Orthopedic System (RIO) with Total Knee Arthroplasty Application is a stereotactic ins… | 2012 |
What descends from it? (44)
See all 443 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2019 | Class II | Z-1823-2019 | Under Investigation by firm | The bearings of the saw attachments were ungreased. |
| Apr 25, 2019 | Class II | Z-1824-2019 | Under Investigation by firm | The bearings of the saw attachments were ungreased. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 9 of the 39 ancestors have a recall of any class.
- Of its descendants, K170581 (Mako Surgical Corp., 2017) has gone furthest, with 38 descendants of its own.
- 2 other devices also cite its predicate K112507.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Robotic Arm Interactive Orthopedic System (RIO®) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The RIO® 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 with which the system is compatible:
» Kinetis Total Knee System { CR/UC)
Triathlon Total Knee System ( CR/CS/PS cemented Primary)
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/K143752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143752: Total Knee Application (TKA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143752
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