# K070108: Elibra Dynamic Knee Balancer

- Pathway: 510(k) (Traditional)
- Applicant: Synvasive Technology, Inc.
- Decided: Apr 4, 2007 after 83 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Libra Dynamic Knee Balancer: named in the summary without a submission number

## Most influential descendants
- K090474: Orthorex Intra-Operative Load Sensor (2009), 30 descendants of its own
- K130380: Orthosensor Knee Balancer (2013), 29 descendants of its own
- K131767: Orthosensor Knee Balancer, Verasense Knee System (2013), 28 descendants of its own
- K150372: VERASENSE Knee System (2016), 27 descendants of its own
- K132104: Elibra Soft-Tissue Force Sensor (2014), 13 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K070108
Methodology: https://510kreport.com/methodology