510(k) · Cleared
ClearedElibra Dynamic Knee Balancer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synvasive Technology, Inc. · ONN Intraoperative Orthopedic Joint Assessment Aid
Cleared on Apr 4, 2007 after an 83-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.
- Decided
- Apr 4, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly.
- This deviceK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- Descendant · cites it directly · 30 of its ownK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- Descendant · 2 generations on · 29 of its ownK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 28 of its ownK131767 Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
- Descendant · 2 generations on · 27 of its ownK150372 VERASENSE Knee SystemOrthosensor, Inc. · 2016
- Descendant · cites it directly · 13 of its ownK132104 Elibra Soft-Tissue Force SensorKamm & Associates · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K090474Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009 · cites it directly30descendants
- K130380Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · 2 generations on29descendants
- K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013 · 3 generations on28descendants
- K150372VERASENSE Knee SystemOrthosensor, Inc. · 2016 · 2 generations on27descendants
- K132104Elibra Soft-Tissue Force SensorKamm & Associates · 2014 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| +1 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| +2 | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | 1 |
| +3 | K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | 2013 | — |
| +2 | K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016 | — |
| +1 | K132104 | Elibra Soft-Tissue Force Sensor | Kamm & Associates | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | — | Libra Dynamic Knee Balancer Named without a submission number |
What descends from it? (33)
See all 333 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?
- Of its descendants, K090474 (Orthosensor, Inc., 2009) has gone furthest, with 30 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. 2007, 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/K070108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070108: Elibra Dynamic Knee Balancer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070108
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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