# K192080: iASSIST Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
- Decided: Nov 5, 2019 after 95 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- 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: 11 generations back to K983831 (1999). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141601: Iassist Knee System, Zimmer Cas (2014) Summary page 4.
- K122326: Smarttools Knee System, Zimmer (2012) Summary page 4.

## Most influential descendants
- K213033: iASSIST Knee System (2022), 0 descendants of its own

## Indications for use
The iASSIST® Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K192080
Methodology: https://510kreport.com/methodology