510(k) · Cleared
Recalled · Class II · 2020Makoplasty Total Hip Allpication, Rio Standard System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corporation · OLO Orthopedic Stereotaxic Instrument
Cleared on Nov 13, 2014 as substantially equivalent to K121064 (Mako Surgical Corporation, 2012) after a 114-day review. Its family tree reaches back 12 generations to 1991. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 13, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 12 generations to K905070 (1991). 50 ancestors in all, the oldest K861692 (1986). 8 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations between
- 3 generations backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 2 generations backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- 1 generation backK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- This deviceK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014
- Descendant · cites it directly · 7 of its ownK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 2 generations on · 6 of its ownK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- Descendant · 3 generations on · 3 of its ownK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- Descendant · 4 generations on · 1 of its ownK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
- Descendant · 3 generations on · 1 of its ownK193515 Mako Total Knee ApplicationMako Surgical Corp. · 2020 · Recalled
Show all 12 generations
- Root · 12 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 10 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 9 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 8 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 7 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 6 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 5 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 4 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 3 generations backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 2 generations backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- 1 generation backK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- This deviceK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170593Mako Total Hip ApplicationMako Surgical Corp. · 2017 · cites it directly7descendants
- K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019 · 2 generations on6descendants
- K193128Mako Total Hip ApplicationMako Surgical Corp. · 2020 · 3 generations on3descendants
- K243751Mako Total Hip Application 5.0Mako Surgical Corp. · 2025 · 4 generations on1descendant
- K193515Mako Total Knee ApplicationMako Surgical Corp. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −11 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −10 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −9 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −8 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −7 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −6 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −5 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −4 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −3 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| −2 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| −1 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| 0 (this device) | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | — |
| +1 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| +2 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| +3 | K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 | — |
| +4 | K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025 | — |
| +3 | K193515 | Mako Total Knee Application | Mako Surgical Corp. | 2020 | 6 |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121064 | Makoplasty Total Hip Application, Rio Standard SystemSummary page 4…AKOplasty Total Hip Application is substantially equivalent to MAKO Surgical’s (Robotic Arm Interactive Orthopedic System) RIO – (Total Hip Arthroplasty) THA cleared via K121064. Device Modifications: MAKO Integrated Cutting System (MICS) Inline offset cup impactor MICS endcap Reamer a… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170593 | Mako Total Hip Application | 2017 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2020 | Class II | Z-2745-2020 | Under Investigation by firm | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. |
| Aug 7, 2017 | Class II | Z-3131-2017 | Software design | Software discrepancy of not showing all the EE constants, when the screen is filled. |
| Dec 22, 2016 | Class II | Z-1411-2017 | Labeling design | Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 12 of the 50 ancestors have a recall of any class.
- Of its descendants, K170593 (Mako Surgical Corp., 2017) has gone furthest, with 7 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. 2014, 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/K141989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141989: Makoplasty Total Hip Allpication, Rio Standard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141989
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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