510(k) · Cleared
Recalled · Class II · 2024Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha
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 Feb 24, 2010 as substantially equivalent to K091998 (Mako Surgical Corp., 2009) and 8 other predicates after a 113-day review. Its family tree reaches back 10 generations to 1991. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 24, 2010
- Review
- 113 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 2
- Predicates
- 9
Its longest line of descent runs back 10 generations to K905070 (1991). 48 ancestors in all, the oldest K861692 (1986). 11 later devices descend from it, 2 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 backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- This deviceK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010
- Descendant · cites it directly · 9 of its ownK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 4 generations on · 6 of its ownK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- Descendant · 5 generations on · 3 of its ownK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
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 backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- This deviceK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · cites it directly9descendants
- K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · 2 generations on8descendants
- K170593Mako Total Hip ApplicationMako Surgical Corp. · 2017 · 3 generations on7descendants
- K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019 · 4 generations on6descendants
- K193128Mako Total Hip ApplicationMako Surgical Corp. · 2020 · 5 generations on3descendants
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 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| 0 (this device) | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | — |
| +1 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| +2 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| +3 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| +4 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| +5 | K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (9)
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 |
|---|---|---|---|
| * | K091998 | Robotic Arm Interactive Orthopedic System-HipSummary page 1…Class 1I Product Code: OLO Substantial Equivalence Claimed To: RIO - THA is substantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosof… | 2009 |
| * | K081867 | Mako Surgical Tactile Guidance System Version 2.0Summary page 1…OLO Substantial Equivalence Claimed To: RIO - THA is substantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364… | 2008 |
| * | K010602 | Vectorvision HipSummary page 1…imed To: RIO - THA is substantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based… | 2001 |
| * | K040368 | Vectorvision Hip 3.0Summary page 1…RIO - THA is substantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Modul… | 2004 |
| * | K052213 | Navigation SW Hip 3.1 on CISummary page 1…A is substantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K05061… | 2005 |
| * | K072716 | Vector Vision HipSummary page 1…tantially equivalent to MAKO Surgical's RIO - Hip (K091998), Tactile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and St… | 2007 |
| * | K022364 | Navitrack System Total Hip Replacement,Model 900.200Summary page 1…ctile Guidance System v2.0 (a~ka. RIO, K081 867), Brainlab's Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and Stryker's Navigation System-Hip Module (K022365). Description: T… | 2003 |
| * | K050615 | Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000Summary page 1…s Vectorvision Hip (K<010602, K040368, K052213, K072716), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and Stryker's Navigation System-Hip Module (K022365). Description: The main RIO platform includes an optical detector, computer… | 2005 |
| * | K022365 | Stryker Navigation System - Hip ModuleSummary page 1…16), Orthosoft's Navitrack System -Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and Stryker's Navigation System-Hip Module (K022365). Description: The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tool… | 2003 |
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Aug 7, 2024 | Class II | Z-0044-2025 | Vendor change control | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. |
| Jan 20, 2011 | Not classified | Z-0146-2012 | Software change control | MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 48 ancestors have a recall of any class.
- Of its descendants, K121064 (Mako Surgical Corporation, 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 and hip 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:
o Unicondylar knee replacement and/or patellofemoral knee replacement
o Total hip arthroplasty (THA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093425 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093425: Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093425
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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