510(k) · Cleared
Recalled · Class II · 2026TMINI Miniature Robotic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
THINK Surgical, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Jul 24, 2026 as substantially equivalent to K260010 (THINK Surgical, Inc., 2026) after a 116-day review. Its family tree reaches back 24 generations to 1991. It has been recalled once.
- Decided
- Jul 24, 2026
- Review
- 116 days
- Class
- Class II
- Product code
- OLO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 24 generations to K905070 (1991). 69 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet.
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 20 generations between
- 3 generations backK252544 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 2 generations backK253661 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 1 generation backK260010 TMINI® Miniature Robotic SystemTHINK Surgical, Inc. · 2026 · Recalled
- This deviceK261024 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
Show all 24 generations
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 23 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 22 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 21 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 20 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 19 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 18 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 17 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 16 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 15 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 14 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 13 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 12 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 11 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 10 generations backK230202 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023 · Recalled
- 9 generations backK232802 TMINI™ Miniature Robotic SystemTHINK Surgical, Inc. · 2023
- 8 generations backK241031 TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc. · 2024
- 7 generations backK242264 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2024
- 6 generations backK243285 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2024
- 5 generations backK243481 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 4 generations backK250877 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 3 generations backK252544 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 2 generations backK253661 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2025
- 1 generation backK260010 TMINI® Miniature Robotic SystemTHINK Surgical, Inc. · 2026 · Recalled
- This deviceK261024 TMINI Miniature Robotic SystemTHINK Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −23 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −22 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −21 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −20 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −19 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −18 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −17 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −16 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −15 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −14 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −13 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −12 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| −11 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −10 | K230202 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | 1 |
| −9 | K232802 | TMINI™ Miniature Robotic System | THINK Surgical, Inc. | 2023 | — |
| −8 | K241031 | TMINI Miniature Robotic System (TMINI 1.1) | THINK Surgical, Inc. | 2024 | — |
| −7 | K242264 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | — |
| −6 | K243285 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2024 | — |
| −5 | K243481 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025 | — |
| −4 | K250877 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025 | — |
| −3 | K252544 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025 | — |
| −2 | K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2025 | — |
| −1 | K260010 | TMINI® Miniature Robotic System | THINK Surgical, Inc. | 2026 | 1 |
| 0 (this device) | K261024 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K260010 | TMINI® Miniature Robotic SystemSummary page 5…n intended use, Indications for Use, design, materials, technology, operational principles and performance to the predicate, TMINI® Miniature Robotic System, cleared via K260010. Device Modification: The purpose of this submission is to introduce an alternate manual cleaning method in addition to the curr… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-0192-2027 | Process control | Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 19 of the 69 ancestors have a recall of any class.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system…
Read the full statement (190 words)
TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is compatible with and to be used with the following knee replacement systems in accordance with the indications and contraindications:
• Enovis™ EMPOWR Knee System®
• Ortho Development® BKS® and BKS TriMax® Knee System
• Total Joint Orthopedics Klassic® Knee System
• United® U2™ Total Knee System
• Medacta® GMK® Sphere / SpheriKA Knee Systems
• Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
• b-ONE MOBIO® Total Knee System
• Maxx Orthopedics Freedom® Total & Titan Knee
• LINK® LinkSymphoKnee System
• Stryker® Triathlon® Knee System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261024: TMINI Miniature Robotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261024
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026