510(k) · Cleared
ClearedOrthosensor Knee Balancer, Verasense 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 Nov 8, 2013 as substantially equivalent to K130380 (Orthosensor, Inc., 2013) after a 144-day review. Its family tree reaches back 3 generations to 2007. 28 later devices descend from it.
- Decided
- Nov 8, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070108 (2007). 28 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- 2 generations backK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- 1 generation backK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- This deviceK131767 Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
- Descendant · cites it directly · 27 of its ownK150372 VERASENSE Knee SystemOrthosensor, Inc. · 2016
- Descendant · 2 generations on · 12 of its ownK163338 OMNIBotics Knee SystemOmnllife Science, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK200888 OMNIBotics Knee SystemCorin, Ltd. · 2020
- Descendant · 4 generations on · 9 of its ownK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK172462 OrthAlign Plus SystemOrthalign, Inc. · 2017
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K150372VERASENSE Knee SystemOrthosensor, Inc. · 2016 · cites it directly27descendants
- K163338OMNIBotics Knee SystemOmnllife Science, Inc. · 2017 · 2 generations on12descendants
- K200888OMNIBotics Knee SystemCorin, Ltd. · 2020 · 3 generations on11descendants
- K221224Real Intelligence CoriBlue Belt Technologies, Inc. · 2022 · 4 generations on9descendants
- K172462OrthAlign Plus SystemOrthalign, Inc. · 2017 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| −2 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| −1 | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | 1 |
| 0 (this device) | K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | 2013 | — |
| +1 | K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016 | — |
| +2 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +3 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
| +4 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| +2 | K172462 | OrthAlign Plus System | Orthalign, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K130380 | Orthosensor Knee BalancerSummary page 1…fin Road, Suite A-310 Dania Beach, FL. 33004 Phone: (954) 577-7770 Fax: (954) 577-7343 [email protected] Date of Summary: October 14, 2013 Predicate 510(k) Number: K130380 - OrthoSensor Knee Balancer Special 510(k) Number: K131767 Trade/Proprietary:OrthoSensor Knee Balancer (Trade / Proprietary name… | 2013 |
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150372 | VERASENSE Knee System | 2016 | 27 |
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 6 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K150372 (Orthosensor, Inc., 2016) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K130380.
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. 2013, 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131767: Orthosensor Knee Balancer, Verasense Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131767
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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