# K213033: iASSIST Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft D/B/A Zimmer Cas
- Decided: Jan 14, 2022 after 115 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: 12 generations back to K983831 (1999). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192080: iASSIST Knee System, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 4.

## Indications for use
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes. The present iASSIST Knee System is designed for Total Knee Arthroplasty.

Source page: https://510kreport.com/device/K213033
Methodology: https://510kreport.com/methodology