510(k) · Cleared
ClearedElibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes
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 Mar 22, 2011 as substantially equivalent to K070108 (Synvasive Technology, Inc., 2007) after a 538-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Mar 22, 2011
- Review
- 538 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070108 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- This deviceK093046 Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models…Synvasive Technology, Inc. · 2011
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) | K093046 | Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes | Synvasive Technology, Inc. | 2011 | — |
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…product code ONN, Regulation: 882.4560 Class of device: Class 2. 2. The legally marketed device to which we are claiming equivalence 1807.92(a)(3)J K070108 eLibra Dynamic Knee Balancer, Synvasive Technology 3. Description of device: The device consists of two units, the force se… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K070108.
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. 2011, 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 eLIBRA®)Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093046: Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093046
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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