510(k) · Cleared
Recalled · Class II · 2014Orthosensor Knee Balancer
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 13, 2013 as substantially equivalent to K090474 (Orthosensor, Inc., 2009) after a 119-day review. Its family tree reaches back 2 generations to 2007. 29 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- ONN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070108 (2007). 29 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- 1 generation backK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- This deviceK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013
- Descendant · cites it directly · 28 of its ownK131767 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
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013 · cites it directly28descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| −1 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| 0 (this device) | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K090474 | Orthorex Intra-Operative Load SensorSummary page 1…orp. Pkwy, 4t Floor ™ Sunrise, FL 33323 Phone: (954)577-7770 Fax: (954) 577-7343 [email protected] Date of Summary: February 8, 2013 Predicate 510(k) Number: K090474 Special 510(k) Number: K130380 Trad(; / Proprietary Names: OrthoSensor Knee Balancer Classification Name: Intraoperative Ortho… | 2009 |
What descends from it? (29)
See all 292 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 |
|---|---|---|---|---|
| Dec 5, 2014 | Class II | Z-1029-2015 | Under Investigation by firm | Presence of one inoperable (dead) sensor pad. |
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 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131767 (Orthosensor, Inc., 2013) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K090474.
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 Knee Balancer 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/K130380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130380: Orthosensor Knee Balancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130380
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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