510(k) · Cleared
ClearedRobotic Arm Interactive Orthopedic System-Hip
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 Sep 28, 2009 as substantially equivalent to K083644 (Mako Surgical Corp., 2009) and 6 other predicates after an 88-day review. Its family tree reaches back 9 generations to 1991. 12 later devices descend from it.
- Decided
- Sep 28, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K905070 (1991). 44 ancestors in all, the oldest K861692 (1986). 12 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 5 generations between
- 3 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 2 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- This deviceK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
- Descendant · cites it directly · 11 of its ownK093425 Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · Recalled
- Descendant · 2 generations on · 9 of its ownK121064 Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- Descendant · 3 generations on · 8 of its ownK141989 Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · Recalled
- Descendant · 4 generations on · 7 of its ownK170593 Mako Total Hip ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 5 generations on · 6 of its ownK191998 Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019
Show all 9 generations
- Root · 9 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 8 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 7 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 6 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 5 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 4 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 3 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 2 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 1 generation backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- This deviceK091998 Robotic Arm Interactive Orthopedic System-HipMako Surgical Corp. · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K093425Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaMako Surgical Corp. · 2010 · cites it directly11descendants
- K121064Makoplasty Total Hip Application, Rio Standard SystemMako Surgical Corporation · 2012 · 2 generations on9descendants
- K141989Makoplasty Total Hip Allpication, Rio Standard SystemMako Surgical Corporation · 2014 · 3 generations on8descendants
- K170593Mako Total Hip ApplicationMako Surgical Corp. · 2017 · 4 generations on7descendants
- K191998Mako Total Hip Application, Mako Total Knee ApplicationMako Surgical Corp. · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −8 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −7 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −6 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −5 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −4 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −3 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −2 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −1 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| 0 (this device) | 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 |
| +2 | K121064 | Makoplasty Total Hip Application, Rio Standard System | Mako Surgical Corporation | 2012 | 12 |
| +3 | K141989 | Makoplasty Total Hip Allpication, Rio Standard System | Mako Surgical Corporation | 2014 | 3 |
| +4 | K170593 | Mako Total Hip Application | Mako Surgical Corp. | 2017 | 1 |
| +5 | K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | 2019 | — |
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 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K083644 | Mako Surgical Tactile Guidance System-HipSummary page 1…LO Substantial Equivalence Claimed To: RIO - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081 867), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716)… | 2009 |
| * | K081867 | Mako Surgical Tactile Guidance System Version 2.0Summary page 1…ivalence Claimed To: RIO - Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081 867), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total… | 2008 |
| * | K010602 | Vectorvision Hip | 2001 |
| * | K040368 | Vectorvision Hip 3.0Summary page 1…ical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081 867), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).… | 2004 |
| * | K052213 | Navigation SW Hip 3.1 on CISummary page 1…ctile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081 867), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Descript… | 2005 |
| * | K072716 | Vector Vision HipSummary page 1…Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081 867), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The… | 2007 |
| * | K022364 | Navitrack System Total Hip Replacement,Model 900.200Summary page 1…7), Brainlab's Vectorvision Hip (K0l 0602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364). Description: The main platform includes an optical detector, computer, dedicated instrumentation,… | 2003 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha | 2010 | 11 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 44 ancestors have a recall of any class.
- Of its descendants, K093425 (Mako Surgical Corp., 2010) has gone furthest, with 11 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. 2009, 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 Acetabular reaming during total hip arthoplasty (THA)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K091998: Robotic Arm Interactive Orthopedic System-Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K091998
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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