510(k) · Cleared
ClearedTSolution One Total Knee Application
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 Apr 1, 2021 as substantially equivalent to K203040 (THINK Surgical, Inc., 2020) after a 27-day review. Its family tree reaches back 19 generations to 1999.
- Decided
- Apr 1, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K983831 (1999). 79 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet.
- Root · 19 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 15 generations between
- 3 generations backK193135 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- 2 generations backK201255 TSolution® One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- 1 generation backK203040 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- This deviceK210668 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2021
Show all 19 generations
- Root · 19 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 18 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 17 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 16 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 15 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 14 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 13 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 12 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 11 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 10 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 9 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 8 generations backK150741 TSolution One w/ACG surgical SystemTHINK Surgical, Inc. · 2015
- 7 generations backK153647 TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc. · 2016
- 6 generations backK162195 TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. · 2016
- 5 generations backK170430 TSolution One Surgical System Model 210THINK Surgical, Inc. · 2017
- 4 generations backK191369 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- 3 generations backK193135 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- 2 generations backK201255 TSolution® One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- 1 generation backK203040 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- This deviceK210668 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −18 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −17 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −16 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −15 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −14 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −13 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −12 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −11 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −10 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −9 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −8 | K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015 | — |
| −7 | K153647 | TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | 2016 | — |
| −6 | K162195 | TSolution One Cup1 Surgical System | THINK Surgical, Inc. | 2016 | — |
| −5 | K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | 2017 | — |
| −4 | K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | — |
| −3 | K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | — |
| −2 | K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020 | — |
| −1 | K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2020 | — |
| 0 (this device) | K210668 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K203040 | TSolution One Total Knee ApplicationSummary page 4…substantially equivalent in intended use, Indications for Use, design, materials, technology, operational principles and performance to the predicate device cleared via K203040. Device Modification: The purpose of this submission is to add three more FDA cleared knee implant systems that are compatible… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 79 ancestors have a recall of any class.
- 1 other device also cites its predicate K203040.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool are…
Read the full statement (231 words)
The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).
The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.
The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:
• Aesculap Columbus Knee System
• Corin Unity Knee
• DJO Surgical EMPOWR 3D Knee
• DJO Surgical EMPOWR Knee System
• Ortho Development Balanced Knee
• Total Joint Orthopedics Klassic Knee System
• United U2 Knee
• Zimmer Biomet Persona
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210668: TSolution One Total Knee Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210668
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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