510(k) · Cleared
Recalled · Class II · 2022Makoplasty Total Hip Application, 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 Jun 6, 2012 as substantially equivalent to K093425 (Mako Surgical Corp., 2010) after a 61-day review. Its family tree reaches back 11 generations to 1991. 9 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 6, 2012
- Review
- 61 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 11 generations to K905070 (1991). 49 ancestors in all, the oldest K861692 (1986). 9 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 backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 1 generation backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- This deviceK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012
- Descendant · cites it directly · 8 of its ownK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
- Descendant · 4 generations on · 3 of its ownK193128 Mako Total Hip ApplicationMako Surgical Corp. · 2020
- Descendant · 5 generations on · 1 of its ownK243751 Mako Total Hip Application 5.0Mako Surgical Corp. · 2025
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 backK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- 1 generation backK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- This deviceK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · cites it directly8descendants
- K170593Mako Total Hip ApplicationMako Surgical Corp. · 2017 · 2 generations on7descendants
- K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019 · 3 generations on6descendants
- K193128Mako Total Hip ApplicationMako Surgical Corp. · 2020 · 4 generations on3descendants
- K243751Mako Total Hip Application 5.0Mako Surgical Corp. · 2025 · 5 generations on1descendant
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 | K091998 | Robotic Arm Interactive Orthopedic System-Hip | Mako Surgical Corp. | 2009 | — |
| −1 | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | Mako Surgical Corp. | 2010 | 2 |
| 0 (this device) | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | — |
| +1 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| +2 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| +3 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
| +4 | K193128 | Mako Total Hip Application | Mako Surgical Corp. | 2020 | — |
| +5 | K243751 | Mako Total Hip Application 5.0 | Mako Surgical Corp. | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaSummary page 1…AKOplasty Total Hip Application is substantially equivalent to MAKO Surgical's (Robotic Arm Interactive Orthopedic System) RIO - (Total Hip Arthroplasty) THA cleared via K093425. Description: MAKOplasty Total Hip Application is an upgrade to RIG-THA (K093425). The features of this application are to impro… | 2010 |
| † | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | 2012 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141989 | Makoplasty Total Hip Allpication, Rio Standard System | 2014 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2022 | Class II | Z-1735-2022 | Under Investigation by firm | Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use. |
| Jul 24, 2018 | Class II | Z-2925-2018 | Under Investigation by firm | Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera. |
| 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 |
| Sep 29, 2016 | Class II | Z-1193-2017 | Component change control | Failure of the Offset Cup Reamer Handle not engaging its mating components. |
| Feb 23, 2016 | Class II | Z-1583-2016 | Nonconforming Material/Component | Potential disassociation of the orientation pin. |
| Nov 25, 2015 | Class II | Z-1588-2016 | Component change control | Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table. |
| Jul 16, 2015 | Class II | Z-0224-2016 | Device Design | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. |
| Oct 7, 2014 | Class II | Z-0830-2015 | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Oct 7, 2014 | Class II | Z-0828-2015 | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Oct 7, 2014 | Class II | Z-0829-2015 | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Apr 30, 2014 | Class II | Z-1508-2016 | Process control | Revision of the field manual |
The 5 latest of 12 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 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 49 ancestors have a recall of any class.
- Of its descendants, K141989 (Mako Surgical Corporation, 2014) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K093425.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 istructures 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 Unicondyhar knee replacement and/or patellofemoral knee replacement
o, Total hip arthroplasty (TEA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121064: Makoplasty Total Hip Application, Rio Standard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121064
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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