# K132104: Elibra Soft-Tissue Force Sensor

- Pathway: 510(k) (Special)
- Applicant: Kamm & Associates
- Decided: Mar 21, 2014 after 256 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.
13 later devices descend from it; 1 cites it directly.
0 of 15 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.

## Most influential descendants
- K163338: OMNIBotics Knee System (2017), 12 descendants of its own
- K200888: OMNIBotics Knee System (2020), 11 descendants of its own
- K221224: Real Intelligence Cori (2022), 9 descendants of its own
- K231963: Real Intelligence™ Cori™ (2023), 4 descendants of its own
- K240139: Real Intelligence™ CORI™ (2024), 3 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/K132104
Methodology: https://510kreport.com/methodology