510(k) · Cleared
ClearedVERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosensor, Inc. · ONN Intraoperative Orthopedic Joint Assessment Aid
Cleared on Apr 1, 2020 as substantially equivalent to K172462 (Orthalign, Inc., 2017) after a 100-day review. Its family tree reaches back 15 generations to 1999. 1 later device descends from it.
- Decided
- Apr 1, 2020
- Review
- 100 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K983831 (1999). 52 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 11 generations between
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK193580 VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for…Orthosensor, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220830 TrueBalance™ Surgical SystemThese Three Medical, LLC · 2022
Show all 15 generations
- Root · 15 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 14 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 13 generations backK031770 CI TKR/UkrBrainlab AG · 2003
- 12 generations backK041899 Vectorvision Uni-KneeBrainlab AG · 2004
- 11 generations backK052966 CI Knee, CI MI TKRBrainlab AG · 2006
- 10 generations backK073615 Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee…Brainlab AG · 2008
- 9 generations backK091411 Kneealign SystemOrthalign, Inc. · 2009
- 8 generations backK093998 Kneealign System with Reference SensorOrthalign, Inc. · 2010
- 7 generations backK103829 Kneealign SystemOrthalign, Inc. · 2011
- 6 generations backK130387 Orthoalign Plus SystemOrthalign, Inc. · 2013
- 5 generations backK140331 Orthalign Plus SystemOrthalign, Inc. · 2014
- 4 generations backK153237 OrthAlign Plus SystemOrthalign, Inc. · 2016
- 3 generations backK162962 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 2 generations backK171780 OrthAlign Plus SystemOrthalign, Inc. · 2017
- 1 generation backK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- This deviceK193580 VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for…Orthosensor, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K220830TrueBalance™ Surgical SystemThese Three Medical, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −14 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −13 | K031770 | CI TKR/Ukr | Brainlab AG | 2003 | — |
| −12 | K041899 | Vectorvision Uni-Knee | Brainlab AG | 2004 | — |
| −11 | K052966 | CI Knee, CI MI TKR | Brainlab AG | 2006 | — |
| −10 | K073615 | Brainlab Knee Essential, Brainlab Knee Unlimited CI Knee, CI Knee Unlimited | Brainlab AG | 2008 | — |
| −9 | K091411 | Kneealign System | Orthalign, Inc. | 2009 | — |
| −8 | K093998 | Kneealign System with Reference Sensor | Orthalign, Inc. | 2010 | — |
| −7 | K103829 | Kneealign System | Orthalign, Inc. | 2011 | — |
| −6 | K130387 | Orthoalign Plus System | Orthalign, Inc. | 2013 | — |
| −5 | K140331 | Orthalign Plus System | Orthalign, Inc. | 2014 | — |
| −4 | K153237 | OrthAlign Plus System | Orthalign, Inc. | 2016 | — |
| −3 | K162962 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −2 | K171780 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| −1 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| 0 (this device) | K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer… | Orthosensor, Inc. | 2020 | — |
| +1 | K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 ONN? 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 ONN device
- #1 K262253 Lantern Knee Navigation Unit…score 16.0 · 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 |
|---|---|---|---|
| * | K172462 | OrthAlign Plus SystemSummary page 4…Regulatory Class: II Regulation Number: 21 CFR 882.4560 Product Code: ONN III. PREDICATE DEVICE Predicate Device - OrthAlign Plus System, K172462 Reference Device - VERASENSE for Zimmer Biomet Persona, K180459 IV. DEVICE DESCRIPTION VERASENSE for Zimmer… | 2017 |
| † | K180459 | VERASENSE for Zimmer Biomet Persona | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220830 | TrueBalance™ Surgical System | 2022 | 0 |
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 52 ancestors have a recall of any class.
- Of its descendants, K220830 (These Three Medical, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172462.
How does its category compare?
All ONN devicesONN Intraoperative Orthopedic Joint Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ONN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONN
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONN
5in 2025
MAUDE reports naming product code ONN, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 6 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | 100 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
For use as a tool to measure implant alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193580: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193580
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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