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 Jun 10, 2020 as substantially equivalent to K191369 (THINK Surgical, Inc., 2019) and 1 other predicate after a 30-day review. Its family tree reaches back 17 generations to 1999. 3 later devices descend from it.
- Decided
- Jun 10, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K983831 (1999). 77 ancestors in all, the oldest K811452 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 13 generations between
- 3 generations backK170430 TSolution One Surgical System Model 210THINK Surgical, Inc. · 2017
- 2 generations backK191369 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- 1 generation backK193135 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- This deviceK201255 TSolution® One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK203040 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK252037 CUVIS-joint (CJ150)Curexo, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK210668 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2021
Show all 17 generations
- Root · 17 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 16 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 15 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 14 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 13 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 12 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 11 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 10 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 9 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 8 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 7 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 6 generations backK150741 TSolution One w/ACG surgical SystemTHINK Surgical, Inc. · 2015
- 5 generations backK153647 TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc. · 2016
- 4 generations backK162195 TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. · 2016
- 3 generations backK170430 TSolution One Surgical System Model 210THINK Surgical, Inc. · 2017
- 2 generations backK191369 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- 1 generation backK193135 TSolution One Total Knee ApplicationTHINK Surgical, Inc. · 2019
- This deviceK201255 TSolution® One Total Knee ApplicationTHINK Surgical, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −16 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −15 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −14 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −13 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −12 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −11 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −10 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −9 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −8 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −7 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −6 | K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015 | — |
| −5 | K153647 | TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | 2016 | — |
| −4 | K162195 | TSolution One Cup1 Surgical System | THINK Surgical, Inc. | 2016 | — |
| −3 | K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | 2017 | — |
| −2 | K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | — |
| −1 | K193135 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2019 | — |
| 0 (this device) | K201255 | TSolution® One Total Knee Application | THINK Surgical, Inc. | 2020 | — |
| +1 | K203040 | TSolution One Total Knee Application | THINK Surgical, Inc. | 2020 | — |
| +2 | K252037 | CUVIS-joint (CJ150) | Curexo, Inc. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K191369 | TSolution One Total Knee ApplicationSummary page 4…otal Knee Application is substantially equivalent in intended use, fundamental scientific technology and performance to TSolution One® Total Knee Application cleared via K191369 (primary predicate) and K193135. Device Modification: The following changes have been made to the TSolution® One Total Knee Appl… | 2019 |
| * | K193135 | TSolution One Total Knee ApplicationSummary page 4…tially equivalent in intended use, fundamental scientific technology and performance to TSolution One® Total Knee Application cleared via K191369 (primary predicate) and K193135. Device Modification: The following changes have been made to the TSolution® One Total Knee Application: • Compatible impl… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203040 | TSolution One Total Knee Application | 2020 | 2 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 7 of the 77 ancestors have a recall of any class.
- Of its descendants, K203040 (THINK Surgical, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K191369.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 (217 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:
• Zimmer Persona™ Knee System
• Corin Unity Knee System
• Aesculap Columbus Knee System
• DJO Surgical® EMPOWR 3D Knee® System
• United U2 Knee System
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201255 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201255: TSolution® One Total Knee Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201255
Report an extraction error
Are you the manufacturer?
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