510(k) · Cleared
ClearedOrthorex Intra-Operative Load Sensor
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 Oct 19, 2009 as substantially equivalent to K070108 (Synvasive Technology, Inc., 2007) after a 237-day review. Its family tree reaches back 1 generation to 2007. 30 later devices descend from it.
- Decided
- Oct 19, 2009
- Review
- 237 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070108 (2007). 30 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- This deviceK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- Descendant · cites it directly · 29 of its ownK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K130380Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · cites it directly29descendants
- K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013 · 2 generations on28descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| 0 (this device) | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| +1 | 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 | — |
| +2 | K163338 | OMNIBotics Knee System | Omnllife Science, Inc. | 2017 | — |
| +3 | K200888 | OMNIBotics Knee System | Corin, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K070108 | Elibra Dynamic Knee BalancerSummary page 1…insertion into the space between the tibia and the femur. Predicate Device: Elibra Dynamic Knee Balancer - K070108 Page 7 of 68 Substantial E… | 2007 |
What descends from it? (30)
See all 302 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?
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. 2009, 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 force sensor is sterile, for single patient use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090474: Orthorex Intra-Operative Load Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090474
Report an extraction error
Are you the manufacturer?
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