510(k) · Cleared
ClearedVERASENSE Knee System
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 15, 2016 as substantially equivalent to K131767 (Orthosensor, Inc., 2013) and 2 other predicates after a 427-day review. Its family tree reaches back 4 generations to 2007. 27 later devices descend from it.
- Decided
- Apr 15, 2016
- Review
- 427 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K070108 (2007). 27 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- 3 generations backK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- 2 generations backK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- 1 generation backK131767 Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
- This deviceK150372 VERASENSE Knee SystemOrthosensor, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · 3 generations on · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · cites it directly · 8 of its ownK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK180459 VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 2018 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K163338OMNIBotics Knee SystemOmnllife Science, Inc. · 2017 · cites it directly12descendants
- K200888OMNIBotics Knee SystemCorin, Ltd. · 2020 · 2 generations on11descendants
- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · 3 generations on9descendants
- K172462OrthAlign Plus SystemOrthalign, Inc. · 2017 · cites it directly8descendants
- K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 2018 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| −3 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| −2 | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | 1 |
| −1 | K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | 2013 | — |
| 0 (this device) | K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016 | — |
| +1 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +2 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +3 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +1 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
| +1 | K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K131767 | Orthosensor Knee Balancer, Verasense Knee SystemSummary page 4…Fax: (954) 246-0318 [email protected] Date of Summary: April 14, 2016 Predicate 510(k) Number(s): K131767 – Orthosensor VERASENSE™ Knee System K130380 - Orthosensor VERASENSE™ Knee System K090474 - Orthosensor VERASENSE™ Knee System T… | 2013 |
| * | K130380 | Orthosensor Knee BalancerSummary page 4…[email protected] Date of Summary: April 14, 2016 Predicate 510(k) Number(s): K131767 – Orthosensor VERASENSE™ Knee System K130380 - Orthosensor VERASENSE™ Knee System K090474 - Orthosensor VERASENSE™ Knee System Traditional 510(k) Number: K150372 Trade/Prop… | 2013 |
| * | K090474 | Orthorex Intra-Operative Load SensorSummary page 4…[email protected] Date of Summary: April 14, 2016 Predicate 510(k) Number(s): K131767 – Orthosensor VERASENSE™ Knee System K130380 - Orthosensor VERASENSE™ Knee System K090474 - Orthosensor VERASENSE™ Knee System Traditional 510(k) Number: K150372 Trade/Proprietary: VERASENSE™ Knee System Classificati… | 2009 |
What descends from it? (27)
See all 273 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)
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 9 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K163338 (Omnllife Science, Inc., 2017) has gone furthest, with 12 descendants of its own.
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. 2016, 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 Knee System 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 Knee System is sterile, for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150372 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150372: VERASENSE Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150372
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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