510(k) · Cleared
Recalled · Class II · 2018Restoris Partial Knee Application (Pka), 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 Mar 1, 2012 as substantially equivalent to K081867 (Mako Surgical Corp., 2008) after a 184-day review. Its family tree reaches back 9 generations to 1991. 46 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 1, 2012
- Review
- 184 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 9 generations to K905070 (1991). 38 ancestors in all, the oldest K861692 (1986). 46 later devices descend from it, 3 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 deviceK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012
- Descendant · cites it directly · 44 of its ownK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- Descendant · 2 generations on · 38 of its ownK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- Descendant · 3 generations on · 37 of its ownK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- Descendant · 4 generations on · 29 of its ownK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- Descendant · 5 generations on · 10 of its ownK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
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 deviceK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K143752Total Knee Application (TKA)Mako Surgical Corp. · 2015 · cites it directly44descendants
- K170581Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 2 generations on38descendants
- K172219Mako Total Knee ApplicationMako Surgical Corp. · 2017 · 3 generations on37descendants
- K182964ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019 · 4 generations on29descendants
- K230202TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · 5 generations on10descendants
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) | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | — |
| +1 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| +2 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| +3 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| +4 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| +5 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 1 |
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 | 2 | 0 |
| 2017 | 5 | 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 |
|---|---|---|---|
| * | K081867 | Mako Surgical Tactile Guidance System Version 2.0Summary page 1…echnological RetrsPATactile Guidance System v2.O a.k.a Characteristics RsoiPIARIO (K081867) Guidance module, robotic arm, camera Guidance module, robotic arm, camera Major Components stand, drill sys… | 2008 |
What descends from it? (46)
See all 463 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 |
|---|---|---|---|---|
| Jul 24, 2018 | Class II | Z-2924-2018 | 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-3130-2017 | Software design | Software discrepancy of not showing all the EE constants, when the screen is filled. |
| Jun 7, 2017 | Class II | Z-2741-2017 | Employee error | An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. |
| 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. |
| Jan 22, 2015 | Class II | Z-1128-2015 | Device Design | When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated |
| Apr 30, 2014 | Class II | Z-1508-2016 | Process control | Revision of the field manual |
The 5 latest of 6 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 2.1 years on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K143752 (Mako Surgical Corp., 2015) has gone furthest, with 44 descendants of its own.
- 4 other devices also cite its predicate K081867.
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 Restoris Partial Knee Application (PKA), for use with 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 Restoris Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in…
Read the full statement (103 words)
The Restoris Partial Knee Application (PKA), for use with 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 Restoris Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (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 unicondylar knee replacement and/or patellofemoral knee replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112507: Restoris Partial Knee Application (Pka), 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/K112507
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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