# K093046: Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes

- Pathway: 510(k) (Traditional)
- Applicant: Synvasive Technology, Inc.
- Decided: Mar 22, 2011 after 538 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
Longest line of descent: 1 generation back to K070108 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070108: Elibra Dynamic Knee Balancer, Synvasive Technology, Inc. (2007) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K093046
Methodology: https://510kreport.com/methodology