510(k) · Cleared
Recalled · Class II · 2018VERASENSE for Zimmer Biomet Persona
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 Jun 7, 2018 as substantially equivalent to K150372 (Orthosensor, Inc., 2016) after a 107-day review. Its family tree reaches back 5 generations to 2007. 5 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 7, 2018
- Review
- 107 days
- Class
- Class II
- Product code
- ONN
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 5 generations to K070108 (2007). 5 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- 4 generations backK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- 3 generations backK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- 2 generations backK131767 Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
- 1 generation backK150372 VERASENSE Knee SystemOrthosensor, Inc. · 2016
- This deviceK180459 VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK241298 QuadsenseEventum Orthopaedics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252524 Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220830 TrueBalance™ Surgical SystemThese Three Medical, LLC · 2022
- Descendant · cites it directly · 0 of its ownK200587 VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech…Orthosensor, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK200665 VERASENSE for Stryker TriathlonOrthosensor, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K241298QuadsenseEventum Orthopaedics, Ltd. · 2024 · cites it directly1descendant
- K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd. · 2025 · 2 generations on0descendants
- K220830TrueBalance™ Surgical SystemThese Three Medical, LLC · 2022 · cites it directly0descendants
- K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…Orthosensor, Inc. · 2020 · cites it directly0descendants
- K200665VERASENSE for Stryker TriathlonOrthosensor, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| −4 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| −3 | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | 1 |
| −2 | K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | 2013 | — |
| −1 | K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016 | — |
| 0 (this device) | K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018 | — |
| +1 | K241298 | Quadsense | Eventum Orthopaedics, Ltd. | 2024 | — |
| +2 | K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | 2025 | — |
| +1 | K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022 | — |
| +1 | K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe… | Orthosensor, Inc. | 2020 | — |
| +1 | K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K150372 | VERASENSE Knee SystemSummary page 4…eotaxic instrument Regulatory Class: II Regulation Number: 21 CFR 882.4560 Product Code: ONN III. PREDICATE DEVICE VERASENSE Knee System, K150372 IV. DEVICE DESCRIPTION VERASENSE provides a means to dynamically balance the knee during primary or revision T… | 2016 |
What descends from it? (5)
4 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 12, 2018 | Class II | Z-0086-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Jul 12, 2018 | Class II | Z-0085-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Jul 12, 2018 | Class II | Z-0087-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Jul 12, 2018 | Class II | Z-0082-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Jul 12, 2018 | Class II | Z-0083-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Jul 12, 2018 | Class II | Z-0084-2019 | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
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 11 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K241298 (Eventum Orthopaedics, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K150372.
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. 2018, 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 is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180459: VERASENSE for Zimmer Biomet Persona.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180459
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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